MedWorm: Adipex

PHENTERMINE HYDROCHLORIDEcapsule [Lannett Company, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 03 Feb 2012 05:00:00 +0100

Updated Date: Feb 3, 2012 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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Obesity control drug by generic firm Lannett approved by FDA

bizjournals.com Health Care:Biotechnology headlines — Tue, 31 Jan 2012 16:10:50 +0100

Lannett Co. Inc. received its second approval for a generic drug product this week when the Food and Drug Administration cleared its application for phentermine hydrochloride capsules for use in the short-term management of obesity. Its product will join other generic phentermine products that generated sales of about $11 million last year, according to the pharmaceutical information services and publishing company Wolters Kluwer. Lannett (NYSE Amex:LCI) of Philadelphia said it expects to begin shipping the product shortly... (Source: bizjournals.com Health Care:Biotechnology headlines)

ADIPEX-P (Phentermine Hydrochloride) Tablet [PD-Rx Pharmaceuticals, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Mon, 30 Jan 2012 05:00:00 +0100

Updated Date: Jan 30, 2012 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Phentermine: Ischaemic colitis: case report

Reactions — Mon, 23 Jan 2012 18:35:21 +0100

(Source: Reactions)

The combination of phentermine and topiramate is an effective adjunct to diet and lifestyle modification for weight loss and measures of comorbidity in overweight or obese adults with additional metabolic risk factors

Evidence-Based Medicine — Mon, 23 Jan 2012 05:00:00 +0100

Context Obesity is a growing epidemic with multiple associated comorbidities including type 2 diabetes, hypertension and hyperlipidaemia. Multiple studies have shown that weight loss can improve these obesity RR factors. But weight loss is difficult. There is an urgent need for new and more efficacious pharmacological treatments to help curtail this growing epidemic. There have been previous studies looking at the use of phentermine and topiramate as single agents for weight loss. In the CONQUER trial, Gadde and colleagues have asked whether a combination of these two agents could provide a more effective treatment option for obesity with fewer side effects. Methods The CONQUER trial is a randomised controlled trial to assess the effects of two different doses of the combination of control...

ADIPEX-P (Phentermine Hydrochloride) Tablet [Physicians Total Care, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 18 Jan 2012 05:00:00 +0100

Updated Date: Jan 18, 2012 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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PHENTERMINE HYDROCHLORIDEtablet [H.J. Harkins Company, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 30 Dec 2011 05:00:00 +0100

Updated Date: Dec 30, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

In Utero Exposure to Qnexa Tied to Higher Rate of Oral ...In Utero Exposure to Qnexa Tied to Higher Rate of Oral ...

Medscape Medical News Headlines — Fri, 23 Dec 2011 04:45:30 +0100

Infants of women exposed during pregnancy to its weight-loss pill Qnexa (topiramate/phentermine) had a higher prevalence of oral clefts than a control group. Reuters Health Information (Source: Medscape Medical News Headlines)

Valvular heart disease with the use of fenfluramine-phentermine.

Texas Heart Institute Journal — Mon, 19 Dec 2011 09:30:03 +0100

Authors: Surapaneni P, Vinales KL, Najib MQ, Chaliki HP Abstract Exposure to the anorectic drug fenfluramine, alone or in combination with phentermine, a noradrenergic central nervous system stimulant, has been associated with unusual cardiac valvular morphology and resultant regurgitation of the left- and right-sided heart valves. The prevalence of significant valvular disease associated with the use of these anorectic drugs is reported to be as high as 23%. Herein, we report the occurrence of multivalvular disease and pulmonary hypertension associated with fenfluramine-phentermine use, discovered in an obese 59-year-old woman before expected gastric bypass surgery. PMID: 22163141 [PubMed - in process] (Source: Texas Heart Institute Journal)

Phentermine/Topiramate Drug Keeps Weight Off for 2 YearsPhentermine/Topiramate Drug Keeps Weight Off for 2 Years

Medscape Pharmacist Headlines — Fri, 16 Dec 2011 23:26:11 +0100

An experimental diet drug seems to help some obese people shed pounds, and keep them off for two years, researchers report. Reuters Health Information (Source: Medscape Pharmacist Headlines)

Combination phentermine and topiramate drug keeps weight off for 2 years

Modern Medicine — Thu, 15 Dec 2011 05:00:00 +0100

NEW YORK (Reuters Health) - An experimental diet drug seems to help some obese people shed pounds, and keep them off for two years, researchers report. (Source: Modern Medicine)

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PHENTERMINE HYDROCHLORIDEtablet [Preferred Pharmaceuticals, Inc]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 14 Dec 2011 05:00:00 +0100

Updated Date: Dec 14, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEcapsule [H.J. Harkins Company, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Mon, 05 Dec 2011 05:00:00 +0100

Updated Date: Dec 5, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

SUPRENZA (Phentermine Hydrochloride) Tablet, Orally Disintegrating [Akrimax Pharmaceuticals, LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 02 Dec 2011 05:00:00 +0100

Updated Date: Dec 2, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

FDA Looking Again at Qnexa for Weight Loss FDA Looking Again at Qnexa for Weight Loss

Medscape Today Headlines — Thu, 10 Nov 2011 17:02:28 +0100

The US FDA is once again reviewing the antiobesity medication phentermine/topiramate, with a decision on approval expected next April. Heartwire (Source: Medscape Today Headlines)

FDA looking again at Qnexa for weight loss

theHeart.org — Wed, 09 Nov 2011 20:00:30 +0100

The US FDA is once again reviewing the antiobesity medication phentermine/topiramate, with a decision on approval expected next April. (Source: theHeart.org)

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Controlled-Release Phentermine/Topiramate in Severely Obese Adults: A Randomized Controlled Trial (EQUIP).

Obesity — Thu, 03 Nov 2011 04:00:00 +0100

Authors: Allison DB, Gadde KM, Garvey WT, Peterson CA, Schwiers ML, Najarian T, Tam PY, Troupin B, Day WW Abstract A 56-week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled-release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI ≥ 35 kg/m(2)) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced-energy diet. Primary end points were percent WL and proportions of patients achieving 5% WL. Secondary end points included waist circumference (WC), systolic and diastolic blood pressure (BP), fasting glucose, and lipid measures. In the primary analysis (randomized patients with at least one postbaseli...

Obesity Drug Eyeing Limited Patient Population: Women of childbearing age are excluded in revised application for topiramate/phentermine combo.

Clinical Endocrinology News — Tue, 01 Nov 2011 04:00:00 +0100

Vivus's resubmission to the Food and Drug Administration of the new drug application for its obesity drug Qnexa (topiramate/phentermine) is for a severely limited patient population that excludes all women under 55 years of age. (Source: Clinical Endocrinology News)

Phentermine: Psychosis: 4 case reports

Reactions — Wed, 26 Oct 2011 13:05:18 +0100

(Source: Reactions)

Phentermine for weight loss: Can it help?

MayoClinic.com - Ask a Specialist — Sun, 23 Oct 2011 01:45:04 +0100

Phentermine, a prescription medication, can help with weight loss when combined with diet and exercise. (Source: MayoClinic.com - Ask a Specialist)

PHENTERMINE HYDROCHLORIDEtablet [PD-Rx Pharmaceuticals, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 20 Oct 2011 05:00:00 +0100

Updated Date: Oct 20, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Vivus resubmits NDA for Qnexa

Drug Topics - Top News — Mon, 17 Oct 2011 04:00:00 +0100

Vivus has resubmitted its New Drug Application (NDA) for Qnexa (phentermine/topiramate) to FDA. (Source: Drug Topics - Top News)

Lannett adds generic weight loss, schizophrenia drugs

bizjournals.com Health Care:Physician Practices headlines — Fri, 14 Oct 2011 18:46:54 +0100

Lannett Co. Inc. said Friday it has started shipping three products — diethylpropion tablets, Phentermine HCI Capsules and Loxapine capsules — recently approved by the Food and Drug Administration. “Sales of the three products augment and strengthen our growing product offering, and we expect will be solid contributors to both sales and profits in fiscal 2012,” said Arthur P. Bedrosian, president and CEO of Lannett (NYSE Amex:LCI). Diethylpropion and Phentermine are weight loss medicines... (Source: bizjournals.com Health Care:Physician Practices headlines)

PHENTERMINE HYDROCHLORIDEcapsule [Eon Labs, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 28 Sep 2011 05:00:00 +0100

Updated Date: Sep 28, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEtablet [Preferred Pharmaceuticals, Inc]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 22 Sep 2011 05:00:00 +0100

Updated Date: Sep 22, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Sustained Weight Loss With Controlled-Release Phentermine/Topiramate May Improve Metabolic Syndrome Traits

Health News from Medical News Today — Tue, 20 Sep 2011 14:00:00 +0100

Long-term weight loss with controlled-release phentermine/topiramate appears to reverse metabolic syndrome and improve associated traits, according to results released at the 47th European Society for the Study of Diabetes (EASD) Annual Meeting. Hermann Toplak, MD, Medical University of Graz in Graz, Austria, and colleagues evaluated the long-term effects of controlled-release phentermine/topiramate as an adjunct to lifestyle intervention on weight loss and the metabolic syndrome over 108 weeks... (Source: Health News from Medical News Today)

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PHENTERMINE HYDROCHLORIDEcapsule [Physicians Total Care, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 13 Sep 2011 05:00:00 +0100

Updated Date: Sep 13, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Phentermine therapy for obesity does not elevate blood pressure

Diabetes, Obesity and Metabolism — Wed, 07 Sep 2011 01:45:51 +0100

(Source: Diabetes, Obesity and Metabolism)

Novel Weight Loss Drug Under FDA Review

Rheumatology News — Thu, 01 Sep 2011 04:00:00 +0100

LAS VEGAS – The investigational, controlled-release phentermine/topiramate combination produced significant weight loss that was associated with significantly improved quality of life in two studies of overweight and obese individuals. (Source: Rheumatology News)

Weight Loss Drug Combo May Improve QOL

Clinical Endocrinology News — Thu, 01 Sep 2011 04:00:00 +0100

Major Finding: The proportions of patients achieving a meaningful change in weight-related quality of life ranged from 30%-36% with placebo, 37%-52% with the lower phentermine/topiramate dose, and 49%-52% with the higher dose. (Source: Clinical Endocrinology News)

RE: Pulmonary Hypertension Associated with Use of Phentermine?

Yonsei Medical Journal — Mon, 15 Aug 2011 13:51:44 +0100

Authors: Hendricks EJ, Rothman RB PMID: 21786457 [PubMed - in process] (Source: Yonsei Medical Journal)

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PHENTERMINE HYDROCHLORIDEtablet [Physicians Total Care, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 12 Aug 2011 05:00:00 +0100

Updated Date: Aug 12, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE RESINcapsule, Extended Release [Lannett Company, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 12 Aug 2011 05:00:00 +0100

Updated Date: Aug 12, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Obese Patients Treated With QNEXA Demonstrated Significant Improvement In Quality Of Life

Health News from Medical News Today — Sat, 06 Aug 2011 08:00:00 +0100

VIVUS, Inc. (NASDAQ: VVUS) announced that additional data from the phase 3 QNEXA studies will be presented during the American Association of Diabetes Educators (AADE) meeting in Las Vegas, NV. Ronette L. Kolotkin, PhD, a clinical psychologist from Obesity and Quality of Life Consulting, Consulting Professor at Duke University Medical Center, and former Director of the Behavioral Program at Duke University's Diet & Fitness Center, will give an oral presentation today entitled, "Quality of Life is Improved With Controlled-Release Phentermine/Topiramate In Overweight and Obese Patients." Dr... (Source: Health News from Medical News Today)

Obesity Treatment - FDA Approves Phentermine Resin Extended-Release Capsules

Health News from Medical News Today — Wed, 03 Aug 2011 14:00:00 +0100

Lannett Company, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for Phentermine Resin Extended-Release Capsules, 15 mg and 30 mg. This is the fourth product approval for Lannett within the last five weeks. Phentermine Resin Extended-Release Capsules, 15 mg and 30 mg will be sold through bariatric clinics and are the therapeutic equivalent to the reference listed drug, Ionamin® Capsules, 15 mg and 30 mg, of UCB, Inc. Arthur P... (Source: Health News from Medical News Today)

Lannett Receives FDA Approval for Phentermine Resin Extended-Release Capsules, 15 mg and 30 mg

Drugs.com - Pharma News — Mon, 01 Aug 2011 13:26:55 +0100

PHILADELPHIA--(BUSINESS WIRE)--Jul 29, 2011 - Lannett Company, Inc. (NYSE AMEX: LCI) today announced the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for Phentermine Resin Extended-Release Capsules, 15... (Source: Drugs.com - Pharma News)

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PHENTERMINE HYDROCHLORIDEcapsule [Lannett Company, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 29 Jul 2011 05:00:00 +0100

Updated Date: Jul 29, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Rhabdomyolysis and phentermine: Coincidence, not causation.

American Journal of Health-System Pharmacy : AJHP — Wed, 27 Jul 2011 10:33:31 +0100

Authors: Hendricks EJ PMID: 21785022 [PubMed - in process] (Source: American Journal of Health-System Pharmacy : AJHP)

Lannett Receives FDA Approval For Phentermine HCl Capsules, 37.5 mg

Pharmaceutical Online News — Wed, 20 Jul 2011 19:33:00 +0100

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) of Phentermine HCl Capsules, 37.5 mg. (Source: Pharmaceutical Online News)

PHENTERMINE HYDROCHLORIDE (Phentermine Hydrochloride) Capsule [Bryant Ranch Prepack]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 19 Jul 2011 05:00:00 +0100

Updated Date: Jul 19, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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[Correspondence] Phentermine plus topiramate in the treatment of obesity

LANCET — Fri, 08 Jul 2011 23:00:00 +0100

Kishore Gadde and colleagues (April 16, p 1341) conclude that the combination of phentermine and topiramate as an adjunct to diet and lifestyle modification might be a valuable treatment for obesity. (Source: LANCET)

[Correspondence] Phentermine plus topiramate in the treatment of obesity – Authors' reply

LANCET — Fri, 08 Jul 2011 23:00:00 +0100

There is no clear evidence linking phentermine monotherapy (when not used in combination with fenfluramine or dexfenfluramine) to primary pulmonary hypertension or valvular heart disease. (Source: LANCET)

PHENTERMINE HYDROCHLORIDEcapsule [Physicians Total Care, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 30 Jun 2011 05:00:00 +0100

Updated Date: Jun 30, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Suprenza (phentermine hydrochloride) - new on RxList

RxList - New and Updated Drug Monographs — Wed, 29 Jun 2011 07:00:00 +0100

Suprenza (phentermine hydrochloride) drug description - FDA approved labeling for prescription drugs and medications at RxList (Source: RxList - New and Updated Drug Monographs)

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Considering a New Weight-Loss Cocktail: Q&A with Kishore Gadde, MD

DukeHealth.org: Duke Health Features — Tue, 21 Jun 2011 20:08:50 +0100

This study was funded by Vivus, which is seeking FDA approval to market the combination therapy under the trade name Qnexa. In October 2010, the FDA asked the company for more safety data. Why, and does this study satisfy those concerns? In March, the FDA issued a warning regarding the use of topiramate during pregnancy, stating that pregnant women who take the drug are at increased risk of having babies born with cleft lip or cleft palate. Thirty-four women became pregnant while in Qnexa clinical trials, and no birth defects were reported for the babies born -- but pregnant women would not be candidates for use of this drug; there is no reason for women to use weight loss drugs while they are pregnant or trying to become pregnant. What other patients should not take this drug? Topiramate ...

PHENTERMINE HYDROCHLORIDEcapsule [Bryant Ranch Prepack]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 15 Jun 2011 05:00:00 +0100

Updated Date: Jun 15, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEtablet [Bryant Ranch Prepack]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Mon, 13 Jun 2011 05:00:00 +0100

Updated Date: Jun 13, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Weight, BP Reduced With Phentermine/Topiramate

Medscape Today Headlines — Thu, 02 Jun 2011 14:55:42 +0100

There was also a small but statistically significant increase in heart rate among patients treated with the highest dose of phentermine/topiramate, but overall reductions in systolic and diastolic blood pressure led to an improvement in rate pulse pressure, according to investigators. Heartwire (Source: Medscape Today Headlines)

Pooled phentermine/topiramate analysis shows reductions in weight, BP

theHeart.org — Thu, 26 May 2011 14:30:53 +0100

There was also a small but statistically significant increase in heart rate among patients treated with the highest dose of phentermine/topiramate, but overall reductions in systolic and diastolic... For complete story visit theheart.org. (Source: theHeart.org)

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ASH: Cardio Risks of Weight-Loss Combo Downplayed (CME/CE)

MedPage Today Pediatrics — Wed, 25 May 2011 17:13:07 +0100

NEW YORK CITY (MedPage Today) -- There does not appear to be an overall increase in cardiovascular risk associated with the investigational weight-loss combination of controlled-release phentermine and topiramate (Qnexa), an analysis of three randomized trials showed. (Source: MedPage Today Pediatrics)

Phentermine (Duromine) precipitated psychosis.

Rural Remote Health — Wed, 18 May 2011 23:00:00 +0100

Authors: Alexander J, Cheng YH, Choudhary J, Dinesh A PMID: 21595510 [PubMed - as supplied by publisher] (Source: Rural Remote Health)

PHENTERMINE HYDROCHLORIDEcapsule [Physicians Total Care, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 17 May 2011 05:00:00 +0100

Updated Date: May 17, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

[Department of Error] Department of Error

LANCET — Fri, 29 Apr 2011 22:17:39 +0100

Discussion should have read: “A limitation of the study was that endpoint assessments were not available for 31% of the sample…” This correction has been made to the online version as of April 15, 2011, and to the printed paper. (Source: LANCET)

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Blood Pressure and Heart Rate Effects, Weight Loss and Maintenance During Long-Term Phentermine Pharmacotherapy for Obesity.

Obesity — Wed, 27 Apr 2011 23:00:00 +0100

Authors: Hendricks EJ, Greenway FL, Westman EC, Gupta AK There is a perception that phentermine pharmacotherapy for obesity increases blood pressure and heart rate (HR), exposing treated patients to increased cardiovascular risk. We collected data from phentermine-treated (PT) and phentermine-untreated (P0) patients at a private weight management practice, to examine blood pressure, HR, and weight changes. Records of 300 sequential returning patients were selected who had been treated with a low-carbohydrate ketogenic diet if their records included complete weight, blood pressure, and HR data from seven office examinations during the first 12 weeks of therapy. The mean time in therapy, time range, and mode was 92 (97.0), 12-624, and 52 weeks. 14% were normotensive, 52% were prehyperten...

All you need to read in the other general journals

BMJ Online First — Tue, 19 Apr 2011 23:00:00 +0100

New drug combination shows promise for weight loss Lancet 2011; doi:10.1016/S0140-6736(11)60205-5 A phase III trial tested two dose regimens of phentermine plus topiramate against placebo as an... (Source: BMJ Online First)

[Articles] Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial

LANCET — Fri, 15 Apr 2011 20:29:39 +0100

The combination of phentermine and topiramate, with office-based lifestyle interventions, might be a valuable treatment for obesity that can be provided by family doctors. (Source: LANCET)

Obesity drugs backed by study

HealthcareRepublic Pharmacist News — Thu, 14 Apr 2011 23:43:32 +0100

Obesity treatment with the drugs phentermine and topiramate could be a valuable therapy option for GPs, US researchers believe. (Source: HealthcareRepublic Pharmacist News)

Unprecedented Weight Loss Achieved With Experimental Drug

Health News from Medical News Today — Tue, 12 Apr 2011 08:00:00 +0100

An investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial, according to researchers at Duke University Medical Center. Appearing online in The Lancet, the study found that treatment with the controlled-release combination therapy consisting of phentermine and topiramate also achieved significant reductions in blood pressure and hemoglobin A1C... (Source: Health News from Medical News Today)

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Substantial Weight Loss With Phentermine and Topiramate

Modern Medicine — Mon, 11 Apr 2011 23:00:00 +0100

Overweight and obese individuals treated with phentermine and topiramate achieve substantial dose-related weight loss, according to a study published online April 11 in The Lancet. (Source: Modern Medicine)

New weight loss pill trialled

NHS News Feed — Mon, 11 Apr 2011 18:00:00 +0100

Conclusion This large randomised controlled trial describes a study assessing the effects of a new treatment for weight loss in overweight and obese individuals. It is well described and the authors raise the major limitation of their study: the fact that 31% of enrolled people had dropped out of the study by the time of the final assessment at week 56. This is a large dropout rate and it essentially means that the final analyses are based on imputed (inferred) results rather than actual results for many participants. Imputation methods are not necessarily inaccurate, but they are by definition estimates of the true end points for participants. The researchers have not given much focus to this limitation and say that they addressed it by analysing their available data in three different wa...

CONQUER: Diet drug phentermine/topiramate combo cuts weight, CV risk factors

theHeart.org — Mon, 11 Apr 2011 15:00:35 +0100

Almost 50% of subjects taking the higher dose of phentermine plus topiramate lost more than 10% of their body weight. Adverse events that concerned the FDA were rare in the study, but the trial... For complete story visit theheart.org. (Source: theHeart.org)

Experimental Weight-Loss Drug Seems to Work: Study

Pharmacy News - Doctors Lounge — Mon, 11 Apr 2011 00:00:00 +0100

Qnexa, a combo of phentermine and topiramate, did come with side effects, however (Source: Pharmacy News - Doctors Lounge)

New Two Drug Combination For Obesity Compares Favourably With Currently Approved And Emerging Weight-Loss Drugs

Health News from Medical News Today — Sun, 10 Apr 2011 23:00:00 +0100

A new two drug combination (phentermine and topiramate) achieves more than double the weight loss of orlistat, the only drug approved for the long-term treatment of obesity, and compares favourably with drugs in clinical development reported in phase 3 trials*. The findings published Online First in The Lancet also suggest that this promising new treatment has additional metabolic benefits - improving blood pressure, lipids, glycaemia, and inflammatory markers. Obesity is associated with reduced life expectancy and increased mortality from diabetes, heart disease, cancer, and other causes... (Source: Health News from Medical News Today)

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RCT: Low-dose, controlled-release, phentermine plus topiramate in overweight and obese adults (CONQUER)

NeLM - News — Sun, 10 Apr 2011 23:00:00 +0100

Source: Lancet, PharmaTimes Area: News Phentermine, a central noradrenaline-releasing drug, was approved in 1959 for short-term obesity treatment and remains the most widely prescribed anti-obesity drug in the US. Topiramate has been assessed alone for weight reduction in obese patients but dose dependent neuropsychiatric adverse events has hindered its development as monotherapy for obesity. Since several neuronal and peripheral pathways are implicated in the regulation of food intake, satiety, and energy homoeostasis, it has been suggested that combinations of drugs with additive or synergistic effects could overcome the biological compensatory mechanisms, and might improve tolerability if doses could be carefully modulated. The CONQUER study assessed efficacy and safety of t...

Phentermine: Reversible posterior leucoencephalopathy syndrome (first report) leading to intracranial haemorrhage: case report

Reactions — Mon, 04 Apr 2011 16:58:12 +0100

(Source: Reactions)

Dearth of Drugs Leaves Few Options for Obesity: FDA decisions on weight-loss drugs have dimmed prospects for new medical therapies for obesity.

Cardiology News — Thu, 31 Mar 2011 23:00:00 +0100

As studies documenting the toll that obesity and excess weight takes on health and mortality continue to be reported, access to multidisciplinary weight-loss programs remain poor – and the approved weight-loss drugs have dwindled to just orlistat and phentermine. (Source: Cardiology News)

Dearth of Drugs Leaves Few Options for Obesity

Rheumatology News — Thu, 31 Mar 2011 23:00:00 +0100

As studies documenting the toll that obesity and excess weight have on health and mortality continue to be reported, access to multidisciplinary weight-loss programs remain poor – and the approved weight-loss drugs have dwindled to just orlistat and phentermine. (Source: Rheumatology News)

PHENTERMINE HYDROCHLORIDEtablet [TAGI Pharma, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 25 Mar 2011 05:00:00 +0100

Updated Date: Mar 25, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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Simultaneous analysis of psychotropic phenylalkylamines in oral fluid by GC–MS with automated SPE and its application to legal cases

Forensic Science International — Mon, 07 Mar 2011 05:00:00 +0100

In this study, to confirm the presence of phenylalkylamine derivatives and ketamine in oral fluid after screening with an immunoassay, an analytical method using automated solid phase extraction (SPE) and gas chromatography–mass spectrometry (GC–MS) was developed and fully validated according to international guidelines. The applicability of the assay was demonstrated by analyzing of authentic oral fluid samples and the results of oral fluid analysis were compared with those in urine and hair to to evaluate the feasibility of oral fluid in forensic cases. The recovery of phenylalkylamines and ketamine from oral fluid collection devices was also assessed. Oral fluid specimens from 23 drug abuse suspects submitted by the police were collected using Salivette ® (Sarstedt, Nümbrecht, Ger...

Phentermine: Psychosis: case report

Reactions — Sun, 06 Mar 2011 17:02:10 +0100

(Source: Reactions)

Phentermine: Rhabdomyolysis: case report

Reactions — Sun, 06 Mar 2011 17:02:10 +0100

(Source: Reactions)

Dearth of Drugs Leaves Few Options for Obesity

Clinical Endocrinology News — Tue, 01 Mar 2011 00:00:00 +0100

As studies documenting the toll obesity and excess weight has on health and mortality continue to be reported, access to multidisciplinary weight-loss programs remain poor – and the approved weight-loss drugs have dwindled to just orlistat and phentermine. (Source: Clinical Endocrinology News)

ADIPEX-P (Phentermine Hydrochloride) Tablet ADIPEX-P (Phentermine Hydrochloride) Capsule [Gate Pharmaceuticals]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 16 Feb 2011 05:00:00 +0100

Updated Date: Feb 16, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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Elite Pharmaceuticals Announces FDA Approval for Generic Phentermine HCL Tablets

Medical News (via PRIMEZONE) — Fri, 04 Feb 2011 14:30:00 +0100

NORTHVALE, N.J., Feb. 4, 2011 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) announced today the approval of an Abbreviated New Drug Application (ANDA) for phentermine HCl 37.5 mg tablets by the U.S. Food and Drug Administration (FDA). The phentermine HCl tablets are the generic equivalent of the Adipex-P(r) 37.5 mg tablets. The product and its equivalents had annual sales of approximately $40 million in 2010 and there are currently six other approved generic manufacturers plus the innovator. On September 16, 2010, Elite had previously announced the acquisition of the ANDA for this generic product from Epic Pharma LLC ("Epic"). The ANDA approval was granted under Epic Pharma's name and transfer of the ANDA into Elite's name will begin immediately. (...

Pharmacotherapy for Obese Adolescents

Pediatric Clinics of North America — Tue, 01 Feb 2011 00:00:00 +0100

The pharmaceutical search to induce weight loss was precipitated by the United States Food and Drug Administration's (FDA) 1959 formal approval of phentermine for short-term weight loss despite limited research supporting its assertions of weight loss. In addition to sympathomimetic amine products like phentermine, other medications considered in this article include herbal products, sibutramine, orlistat, metformin, and rimonabant. The use of pharmacotherapy for morbidly obese adolescents should be part of a comprehensive weight-loss program that recommends diet, exercise, and behavioral modification. Side effects and the possibility of major adverse effects should be remembered when considering use of these products. (Source: Pediatric Clinics of North America)

PHENTERMINE HYDROCHLORIDEcapsule [TEVA Pharmaceuticals USA Inc]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 26 Jan 2011 05:00:00 +0100

Updated Date: Jan 26, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEtablet [Lannett Company, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 25 Jan 2011 05:00:00 +0100

Updated Date: Jan 25, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

FDA requests birth defect data for Qnexa® (phentermine and topiramate)

NeLM - News — Mon, 24 Jan 2011 00:00:00 +0100

Source: BioSpace Area: News According to reports, the US FDA has requested further data on birth defects in association with topiramate prior to considering the approval of Qnexa® (phentermine and topiramate) for the treatment of obesity in the US. The FDA has asked Vivius Inc to assess the feasibility of analysing existing healthcare databases to determine the historical incidence of oral cleft in offspring of women treated with topiramate for migraine prophylaxis. The company believes that this request has stemmed from two published reports citing two oral clefts in the UK Epilepsy and Pregnancy Register and four (including two isolated cleft lips) from the North American AED Pregnancy Registry. The company notes that there were no reports of any foeta...

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VIVUS Provides Regulatory Update on QNEXA NDA

HSMN NewsFeed — Fri, 21 Jan 2011 15:48:48 +0100

MOUNTAIN VIEW, Calif., Jan. 21, 2011 (HSMN NewsFeed) -- VIVUS, Inc. (Nasdaq:VVUS ) today announced that it held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA®, an investigational dru... Biopharmaceuticals, FDAVIVUS, QNEXA, phentermine, topiramate, obesity (Source: HSMN NewsFeed)

PHENTERMINE HYDROCHLORIDEcapsule [Rebel Distributors Corp]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 21 Jan 2011 05:00:00 +0100

Updated Date: Jan 21, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEcapsule [Eon Labs, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Mon, 03 Jan 2011 05:00:00 +0100

Updated Date: Jan 3, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

VIVUS Files European Marketing Authorization Application for QNEXA(R) in the Treatment of Obesity

HSMN NewsFeed — Mon, 20 Dec 2010 12:59:50 +0100

MOUNTAIN VIEW, Calif., Dec. 20, 2010 (HSMN NewsFeed) -- VIVUS, Inc. (Nasdaq:VVUS ) today announced that the company filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for QNEXA® (phentermine/topiramate) Control... BiopharmaceuticalsVIVUS, QNEXA, phentermine/topiramate, obesity (Source: HSMN NewsFeed)

InShapeMD® Dallas | Phentermine Appetite Suppressant Now...

PRWeb: Medical Pharmaceuticals — Mon, 20 Dec 2010 00:59:47 +0100

The holidays are supposed to be a time of joy, giving and spending time with family. However, for some, the holiday season is reason for stress, anxiety and dread. These negative ingredients are a...(PRWeb December 17, 2010)Read the full story at http://www.prweb.com/releases/2010/12/prweb8028161.htm (Source: PRWeb: Medical Pharmaceuticals)

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ADIPEX-P (Phentermine Hydrochloride) Tablet [Physicians Total Care, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 10 Dec 2010 05:00:00 +0100

Updated Date: Dec 10, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Obesity Organizations Call For A Full And Fair Hearing When The FDA Reviews New Treatments For Obesity

Health News from Medical News Today — Tue, 07 Dec 2010 12:00:00 +0100

The Obesity Society (TOS) and the Obesity Action Coalition (OAC) called on the Food and Drug Administration (FDA) to consider the urgent need for more tools to address the obesity epidemic facing more than 93 million Americans as they convene an advisory panel to review a new treatment for obesity. On December 7, the FDA Endocrine and Metabolic Advisory will review a New Drug Application for Contrave, for the treatment of obesity. In October, the FDA rejected two other newly developed obesity treatments, Qnexa (phentermine/topirimate) and Lorquess (lorcaserin), citing safety concerns... (Source: Health News from Medical News Today)

Detection of phentermine in hair samples from drug suspects

Forensic Science International — Fri, 03 Dec 2010 00:00:00 +0100

Abstract: Phentermine (PT) has been widely used as an anti-obesity drug. This drug has to be used with caution due to its close resemblance with amphetamines in its structure and toxicity profile. Recently, PT is in distribution by illegal modes and is found to be available through sources such as the internet, thus their misuse and/or abuse is threatening to be a serious social issue. In the present study, 32 cases of drug suspects were observed for PT abuse, detected using hair samples for drug analysis. PT and other amphetamines, such as methamphetamine (MA), amphetamine (AP), 3,4-methylenedioxyamphetamine (MDMA) and 3,4-methylenedioxyamphetamine (MDA), were extracted using 1% HCl in methanol for 20h at 38°C. The extracts were derivatized with trifluoroacetic anhydride (TFAA) and analy...

PHENTERMINE HYDROCHLORIDEcapsule [Rebel Distributors Corp]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 01 Dec 2010 05:00:00 +0100

Updated Date: Dec 1, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Phentermine: Pulmonary arterial hypertension: case report

Reactions — Tue, 30 Nov 2010 07:20:09 +0100

(Source: Reactions)

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Rhabdomyolysis associated with phentermine.

American Journal of Health-System Pharmacy : AJHP — Sun, 07 Nov 2010 20:10:21 +0100

Conclusion A 32-year-old man developed rhabdomyolysis after ingesting double the recommended dosage of phentermine for a week in addition to engaging in strenuous activity. PMID: 21048209 [PubMed - in process] (Source: American Journal of Health-System Pharmacy : AJHP)

PHENTERMINE HYDROCHLORIDEcapsule [STAT RX USA LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 05 Nov 2010 05:00:00 +0100

Updated Date: Nov 5, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

FDA Issues Complete Response Letter To VIVUS Regarding New Drug Application For QNEXA®

Health News from Medical News Today — Sat, 30 Oct 2010 08:00:00 +0100

VIVUS, Inc. (Nasdaq: VVUS) announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form... (Source: Health News from Medical News Today)

VIVUS Loss Looks Like A Win (VVUS)

BioHealth Investor — Fri, 29 Oct 2010 13:20:21 +0100

VIVUS, Inc. (NASDAQ: VVUS) is doomed. That is what you would think if you just saw the FDA denial to approve Qnexa for weight loss. Most of the headlines on financial aggregation sites are full of negative headlines…. FDA Nixes VIVUS’ Qnexa, FDA Rejects VIVIS ObesityDrug, VIVUS Fails to Win U.S. Approval; US rejects Highly-Anticipated Diet Drug… and on and on. While the FDA did not approve Qnexa and has asked for more data, the underlying belief now appears to be that despite the headlines Qnexa WILL ultimately be able able to secure FDA approval. VIVIS received a Complete Response Letter from the FDA on its New Drug Application for the investigational new drug QNEXA Controlled-Release Capsules, with the communication that the NDA cannot be approved in its present f...

FDA Rejects Another Weight-Loss Drug

MedPage Today Public Health — Fri, 29 Oct 2010 02:19:45 +0100

WASHINGTON (MedPage Today) -- The FDA has declined to approve the investigational weight-loss pill phentermine/topiramate (Qnexa), marking the second time in a week the agency has rejected a diet drug. (Source: MedPage Today Public Health)

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Qnexa qnixed

Health Facts and Fears — Fri, 29 Oct 2010 00:00:00 +0100

The FDA yesterday rejected drugmaker Vivus’ application to market the weight-loss drug Qnexa, a combination of two existing drugs, phentermine and topiramate. It’s the third setback for a weight-loss drug this month: The FDA last week declined to approve a different drug, lorcaserin, because it caused tumors in rats and earlier forced Meridia off the market because it caused an increased risk of heart attack and stroke in patients with a history of heart disease. (Source: Health Facts and Fears)

Pulmonary hypertension associated with use of phentermine.

Yonsei Medical Journal — Sat, 02 Oct 2010 10:10:22 +0100

Authors: Bang WD, Kim JY, Yu HT, Cho SS, Jang JY, Oh CM, Joung B, Chang HJ Weight-control drugs (known as anorexigens) such as fenfluramine have been linked with pulmonary hypertension in previous reports. In our case, a 29 year old woman was admitted for shortness of breath and was diagnosed with pulmonary hypertension. Three months ago, she had been taking phentermine for five weeks. Other factors that might have contributed to the development of pulmonary hypertension were excluded. With treatment, her symptoms improved. This is the first case that can suggest a possible connection between phenermine single medication with pulmonary hypertension. Phentermine has been considered a relatively safe drug to treat obesity, and further investigation is needed to decide the safety and dosa...

New Long-Term Data On QNEXA Show Significant And Sustained Weight Loss Of Greater Than 10% Over Two Years

Pharmaceutical Online News — Tue, 21 Sep 2010 06:18:00 +0100

VIVUS, Inc. recently announced positive top-line results from a two-year study of QNEXA (phentermine/topiramate) Controlled Release Capsules, an investigational therapy for treatment of obesity, a condition that affects approximately one-third of adult Americans. (Source: Pharmaceutical Online News)

Recent progress and novel perspectives on obesity pharmacotherapy

Arquivos Brasileiros de Endocrinologia e Metabologia — Sat, 18 Sep 2010 06:09:31 +0100

This article aims to present recent data on clinical trials of novel weight-loss drugs with short perspective to enter the market, if approved by the regulatory agencies. This review will discuss the efficacy and safety of these compounds, which include lorcaserin (selective serotonin 5-HT2c agonist), tesofensine (triple monoamine reuptake inhibitor), liraglutide (GLP-1 analogue) and cetilistat (gastrointestinal lipase inhibitor), as well as the combination therapies of bupropion/naltrexone, bupropion/zonisamide, phentermine/topiramate and pramlintide/metreleptin. (Source: Arquivos Brasileiros de Endocrinologia e Metabologia)

PHENTERMINE HYDROCHLORIDEcapsule PHENTERMINE HYDROCHLORIDEtablet [Actavis Totowa LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 15 Sep 2010 05:00:00 +0100

Updated Date: Sep 15, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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Fat Attack: Will Three New Antiobesity Drugs Beat a Checkered Safety History?

Scientific American - Official RSS Feed — Tue, 14 Sep 2010 13:00:00 +0100

Finding safe and effective weight-loss medications has long been a goal for drugmakers and physicians alike--roughly one third of American adults meet the clinical criteria for obesity, according to the Centers for Disease Control and Prevention. This year the U.S. Food and Drug Administration has been reviewing three new antiobesity drugs for government approval. Given the field’s checkered past, however, major questions remain about the risks of pills that pare away the pounds.Although drugs that seem promising early on sometimes prove ineffective or downright dangerous after they hit the market, the obesity field has seen more than its share of failures. In the 1960s amphetamines were touted as the answer to weight loss until they proved habit-forming. The mid-1990s witnessed the ...

Eight-Membered Palladacycles Derived from the Insertion of Olefins into the Pd−C Bond of Ortho-Palladated Pharmaceuticals Phenethylamine and Phentermine. Synthesis of Stable Heck-Type Intermediates Containing Accessible β-Hydrogens and Its Use in the Synthesis of 2-Styrylphenethylamines, Tetrahydroisoquinolines, and Eight-Membered Cyclic Amidines

Organometallics — Mon, 13 Sep 2010 19:48:48 +0100

OrganometallicsDOI: 10.1021/om100738z (Source: Organometallics)

PHENTERMINE HYDROCHLORIDEtablet [Blenheim Pharmacal, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Mon, 13 Sep 2010 05:00:00 +0100

Updated Date: Sep 13, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

For Obesity Drugs, Safety Trumps Efficacy

Cardiology News — Tue, 31 Aug 2010 23:00:00 +0100

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For Obesity Drugs, Safety Trumps Efficacy: Safety profiles to date bode well for two drugs in the pipeline: lorcaserin and liraglutide.

Rheumatology News — Tue, 31 Aug 2010 23:00:00 +0100

STOCKHOLM — With a scant number of obesity drugs on the worldwide market, new additions are eagerly sought but face tough safety scrutiny. In July, a Food and Drug Administration advisory panel voted against approval of a new obesity formulation, Qnexa, which combines the weight-loss warhorse phentermine plus the epilepsy drug topiramate, because of safety concerns despite evidence of good efficacy. The same week the FDA panel made this recommendation, new findings on sibutramine, an effective agent many physicians rely on for treating obesity, came to light in a report on a 10,000-patient cardiovascular safety trial presented at the International Congress on Obesity. The findings showed sibutramine clearly boosted the risk for nonfatal myocardial infarction and stroke in patients with ...

Randomized controlled trial to investigate the effects of a newly developed formulation of phentermine diffuse‐controlled release for obesity

Diabetes, Obesity and Metabolism — Mon, 30 Aug 2010 06:02:42 +0100

Aim: (Source: Diabetes, Obesity and Metabolism)

PHENTERMINE HYDROCHLORIDEcapsule [Blenheim Pharmacal, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 24 Aug 2010 05:00:00 +0100

Updated Date: Aug 24, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Side Effects Derail Proposed Drug Combo for Weight Loss

Cardiology News — Sat, 31 Jul 2010 23:00:00 +0100

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel voted 10 to 6 against recommending approval of a combination of phentermine and topiramate as a weight loss agent because of concerns over the treatment's risk-benefit profile. (Source: Cardiology News)

Side Effects Block Approval of Drug Combo for Treating Obesity

Clinical Endocrinology News — Sat, 31 Jul 2010 23:00:00 +0100

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel voted 10 to 6 against recommending the approval of a combination of phentermine and topiramate as a weight-loss agent because of concerns over the treatment's risk-benefit profile. (Source: Clinical Endocrinology News)

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Lannett Receives FDA Approval For Phentermine Hydrochloride Capsules USP 30 Mg

Health News from Medical News Today — Thu, 22 Jul 2010 08:00:00 +0100

Lannett Company, Inc. (NYSE AMEX: LCI) announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Phentermine Hydrochloride Blue/White Seed Capsules USP, 30 mg, the generic equivalent of Sandoz, Inc.'s Reference Listed Drug (RLD) Phentermine Hydrochloride Capsules USP, 30 mg. According to Wolters Kluwer, U.S. sales of Phentermine Hydrochloride Capsules USP, 30 mg in 2009 were approximately $36.5 million at Average Wholesale Price (AWP)... (Source: Health News from Medical News Today)

PHENTERMINE HYDROCHLORIDEcapsule [Lannett Company, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 21 Jul 2010 05:00:00 +0100

Updated Date: Jul 21, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

FDA approves Lannett’s generic for Sandoz weight-loss drug

bizjournals.com Health Care:Health Insurance headlines — Tue, 20 Jul 2010 17:43:26 +0100

The Food and Drug Administration granted marketing approval to Lannett Co. Inc. for its generic version of Phentermine hydrochloride, a weight-reduction medicine marketed by Sandoz. (Source: bizjournals.com Health Care:Health Insurance headlines)

VIVUS Comments On FDA Advisory Committee Panel Meeting On QNEXA® (phentermine/topiramate) Controlled Release Capsules For The Treatment Of Obesity

Health News from Medical News Today — Sat, 17 Jul 2010 08:00:00 +0100

VIVUS, Inc. (Nasdaq: VVUS) announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted against the following question: "Based on the current available data, do you believe the overall benefit-risk assessment of PHEN/TPM (QNEXA) is favorable to support its approval for the treatment of obesity in individuals with a BMI 30 kg/m2 or 27 kg/m2 with weight-related co-morbidities?" The three co-morbidities included hypertension, diabetes and dyslipidemia... (Source: Health News from Medical News Today)

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Vivus Comments on FDA Advisory Committee Panel Meeting on Qnexa (phentermine/topiramate) Controlled Release Capsules for the Treatment of Obesity

Drugs.com - New Drug Applications — Fri, 16 Jul 2010 13:07:46 +0100

MOUNTAIN VIEW, Calif., July 15 /PRNewswire-FirstCall/ -- VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted against the following question: "Based on the... (Source: Drugs.com - New Drug Applications)

FDA advisers reject anti-obesity drug Qnexa® (phentermine/topiramate) over safety concerns

NeLM - News — Thu, 15 Jul 2010 23:00:00 +0100

Source: PharmaTimes Area: News PharmaTimes reports that advisers to the United States US Food and Drug Administration have voted 10-6 against recommending approval of the drug Qnexa® (phentermine/topiramate) for the treatment of obesity. Although the advisory panel did not dispute the effectiveness of the drug, the panel felt that the potential side effects such as depression, memory loss, increased heart rate and birth defects outweighed the benefits. The panel also expressed concern that, at just over 12 months, the data provided by the company were not long term enough. (Source: NeLM - News)

Panel Votes Down New Diet Drug

MedPage Today Public Health — Thu, 15 Jul 2010 20:04:06 +0100

GAITHERSBURG, Md. (MedPage Today) -- An FDA advisory panel was divided over whether to recommend the approval of the investigational weight-loss drug phentermine/topiramate (Qnexa), but the Nay votes prevailed 10-6. (Source: MedPage Today Public Health)

FDA Gives Positive Review on Qnexa

MedPage Today Primary Care — Tue, 13 Jul 2010 21:54:47 +0100

The investigational obesity drug Qnexa (MedPage Today) -- a combination of phentermine and topiramate -- could become the first new prescription drug for paring pounds approved in several years, based on review documents released today by the FDA. (Source: MedPage Today Primary Care)

Market watch: Upcoming market catalysts in Q3 2010

Nature Reviews Drug Discovery — Fri, 02 Jul 2010 05:31:39 +0100

Nature Reviews Drug Discovery 9, 507 (2010). doi:10.1038/nrd3225 Author: Michael Hay Efforts to develop new anti-obesity drugs will face a critical test when two of the three therapies currently under consideration by the US FDA for regulatory approval — phentermine/topiramate (developed by Vivus) and lorcaserin hydrochloride (developed by Arena Pharmaceuticals) — come before FDA advisory committees (Source: Nature Reviews Drug Discovery)

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BP Dip With Novel Drug Combo Tied to Weight Loss

Cardiology News — Wed, 30 Jun 2010 23:00:00 +0100

Major Finding: In patients on the highest dose of phentermine plus controlled-release topiramate, systolic blood pressure reductions were significantly lower than with placebo: 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER. (Source: Cardiology News)

Novel Weight-Loss Combo May Lower BP

Family Practice News — Wed, 30 Jun 2010 23:00:00 +0100

PHENTERMINE HYDROCHLORIDEcapsule [Sandoz Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 24 Jun 2010 05:00:00 +0100

Updated Date: Jun 24, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEtablet [Keltman Pharmaceuticals Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 24 Jun 2010 05:00:00 +0100

Updated Date: Jun 24, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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ENDO: Novel Drug Combo May Aid in Weight Loss (CME/CE)

MedPage Today Endocrinology — Mon, 21 Jun 2010 16:38:54 +0100

SAN DIEGO (MedPage Today) -- A combination of phentermine and topiramate (Qnexa) appears to induce weight loss and a decrease in metabolic risk parameters for cardiovascular disease in obese patients, researchers reported here. (Source: MedPage Today Endocrinology)

Enantioselective piezoelectric quartz crystal sensor for d-methamphetamine based on a molecularly imprinted polymer.

Analytical and Bioanalytical Chemistry — Sat, 05 Jun 2010 23:00:00 +0100

Authors: Arenas LF, Ebarvia BS, Sevilla FB A piezoelectric quartz crystal (PQC) sensor based on a molecularly imprinted polymer (MIP) has been developed for enantioselective and quantitative analysis of d-(+)-methamphetamine (d(+)-MA). The sensor was produced by bulk polymerization and the resulting MIP was then coated on the gold electrode of an AT-cut quartz crystal. Conditions such as volume of polymer coating, curing time, type of PQC, baseline solvent, pH, and buffer type were found to affect the sensor response and were therefore optimized. The PQC-MIP gave a stable response to different concentrations of d(+)-MA standard solutions (response time = 10 to 100 s) with good repeatability (RSD = 0.03 to 3.09%; n = 3), good reproducibility (RSD = 3.55%; n = 5), and good reversibility ...

Phentermine cardiovascular safety II: Response to Rothman Hendricks Int J Cardiol. 2009 epub Mar 19

International Journal of Cardiology — Mon, 17 May 2010 00:00:00 +0100

Rothman and Hendricks’ response includes a very informative and comprehensive data review about phentermine. However, our original letter and response was titled : "Cusp tear in bicuspid aortic valve possibly caused by phentermine". This means that we obviously are not sure, while not excluding phentermine as the cause of the cusp tear. (Source: International Journal of Cardiology)

New Weight-Loss Drug Combo on the Horizon

Medscape Today Headlines — Wed, 05 May 2010 14:15:01 +0100

The highest dose of an investigational weight-loss therapy, a combination of very low-dose phentermine and controlled-release topiramate, reduces body weight by around 10% after a year of treatment and has favorable effects on blood pressure, according to analyses presented at a late-breaking trial session. Heartwire (Source: Medscape Today Headlines)

New weight-loss drug combo on the horizon

theHeart.org — Tue, 04 May 2010 14:15:49 +0100

The highest dose of an investigational weight-loss therapy, a combination of very low-dose phentermine and controlled-release topiramate, reduces body weight by around 10% after a year of treatment... For complete story visit theheart.org. (Source: theHeart.org)

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Randomized controlled trial to investigate the effects of a newly developed formulation of phentermine diffuse controlled release for obesity

Diabetes, Obesity and Metabolism — Fri, 30 Apr 2010 23:00:00 +0100

(Source: Diabetes, Obesity and Metabolism)

PHENTERMINE HYDROCHLORIDEtablet [Blenheim Pharmacal, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 22 Apr 2010 05:00:00 +0100

Updated Date: Apr 22, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEtablet PHENTERMINE HYDROCHLORIDEcapsule [Apotheca, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 08 Apr 2010 05:00:00 +0100

Updated Date: Apr 8, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEcapsule [Apotheca, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 07 Apr 2010 05:00:00 +0100

Updated Date: Apr 7, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEtablet [Qualitest Pharmaceuticals]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 19 Mar 2010 05:00:00 +0100

Updated Date: Mar 19, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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Phentermine cardiovascular safety II: Response to Yosefy Int J Cardiol. 2009 Epub Mar 19

International Journal of Cardiology — Mon, 08 Mar 2010 00:00:00 +0100

Abstract: This is the fourth in a series of letters-to-the-editor discussing phentermine and cardiovascular safety. Yosefy et al., in reporting a case of aortic cusp tear in a 28year-old woman with a bicuspid aortic valve, attributed the tear to previous phentermine therapy. Evidence of mitral and tricuspid valve thickening was noted at echocardiography. In replying we pointed out that phentermine-induced valvular heart disease has not been reported and suggested that, since the reference cited for support referred to fenfluramine-induced valvulopathy, the attribution of the cusp tear to phentermine was incorrect.Yosefy replied, asserting that since the patient had no other cardiac risk factor, the tear had to be due to phentermine. In support of his presumption that phentermine therapy ca...

Phentermine Diet Pills or What? Buying Legally and Safely Online

PRWeb: Medical Pharmaceuticals — Wed, 03 Mar 2010 15:19:07 +0100

Internet pharmacy sites selling weight loss medications around the world are common, and often illegal according to many national regulatory bodies such as the DEA. Where a buyer resides dictates whether obesity medications such as Phentermine, the USA's most popular prescription diet pill, can be purchased legally online and from whom; e.g. unlicensed / non-US based pharmacies are prohibited in America (FDA/DEA). Up to now finding a web site to provide advice and pills such as Adipex, Meridia, Xenical and Phentramin-d legally no matter where the buyer is resident was virtually impossible, hence the launch of phentermine-or-what.com (PRWeb Mar 3, 2010) Read the full story at http://www.prweb.com/releases/2010/03/prweb3664334.htm (Source: PRWeb: Medical Pharmaceuticals)

Vivus's Qnexa Will Become Decision Resources' Clinical Gold Standard In 2013 For The Treatment Of Obesity

Obesity / Weight Loss / Fitness News From Medical News Today — Wed, 03 Mar 2010 13:00:00 +0100

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of obesity, Vivus's Qnexa (the phentermine/topiramate combination) will earn Decision Resources' proprietary clinical gold standard in 2013 and through 2018 following its anticipated U.S. approval for the disease in 2011... (Source: Obesity / Weight Loss / Fitness News From Medical News Today)

Obesity in adults

Clinical Evidence — Thu, 11 Feb 2010 23:00:00 +0100

New option(s) added for: Diethylpropion New option for which we found one systematic review. The review found less weight loss with diethylpropion compared with phentermine. Data were from one small RCT and effects of diethylpropion in weight loss are unclear. Categorised as Unknown effectiveness. Mazindol New option for which we found no evidence. Categorised as Unknown effectiveness. Bariatric surgery New option for which we found one systematic review. The review identified two RCTs and three cohort studies assessing the effects of various bariatric surgical techniques (gastric banding, gastric bypass, vertical banded gastroplasty, biliopancreatic diversion, and sleeve gastrectomy) in people with morbid obesity. All studies ...

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PHENTERMINE HYDROCHLORIDEtablet [Rebel Distributors Corp.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 02 Feb 2010 05:00:00 +0100

Updated Date: Feb 2, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

PHENTERMINE HYDROCHLORIDEtablet [Mutual Pharmaceutical]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 28 Jan 2010 05:00:00 +0100

Updated Date: Jan 28, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Enhanced Weight Loss Following Coadministration of Pramlintide With Sibutramine or Phentermine in a Multicenter Trial.

Obesity — Thu, 21 Jan 2010 00:00:00 +0100

Authors: Aronne LJ, Halseth AE, Burns CM, Miller S, Shen LZ Preclinical evidence suggests that pharmacotherapy for obesity using combinations of agents targeted at distinct regulatory pathways may produce robust additive or synergistic effects on weight loss. This randomized placebo-controlled trial examined the safety and efficacy of the amylin analogue pramlintide alone or in combination with either phentermine or sibutramine. All patients also received lifestyle intervention. Following a 1-week placebo lead-in, 244 obese or overweight, nondiabetic subjects (88% female; 41 +/- 11 years; BMI 37.7 +/- 5.4 kg/m(2); weight 103 +/- 19 kg; mean +/- s.d.) received placebo subcutaneously (sc) t.i.d., pramlintide sc (120 microg t.i.d.), pramlintide sc (120 microg t.i.d.) + oral sibutramine (1...

Application for approval of Qnexa (phentermine and topiramate) for obesity submitted to the FDA

NeLM - News — Mon, 04 Jan 2010 00:00:00 +0100

Source: BioSpace Area: News According to BioSpace, a New Drug Application (NDA) has been submitted to the US FDA seeking approval of Qnexa® (controlled-release oral formulation of low dose phentermine and topiramate) for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidaemia or central adiposity. The application follows the completion of a Phase III program, including two year-long studies (EQUIP and CONQUER). (Source: NeLM - News)