MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'contrave'. Sat, 03 Sep 2011 02:56:42 +0100 http://www.medworm.com/index.php?rid=5118997&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FO0w2-RYQDAk%2F Last week, Arena Pharmaceuticals did some advance work surrounding the impending release of crucial data about its Lorqess diet pill, which was denied approval last fall by the FDA due, in part, to concerns the drug may cause tumors in rats and that efficacy was marginal. To allay those fears, the drugmaker conducted one new study and retained a group of independent pathologists to review other data (see this and this). The latest trial showed that concentrations of cerebrospinal fluid exposure were lower in human brains than in rat models given their pill (read here). The results prompted Needham analyst Alan Carr to write investors that the results “may alleviate certain FDA concerns with respect to the potential for brain tumors.” And Arena ceo Jack Lief, who has been critic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5118997 Wed, 10 Aug 2011 13:47:48 +0100 5118997 http://www.medworm.com/index.php?rid=4893913&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZzoVYKju9hA%2F Four months after receiving a complete response letter from the FDA for its Contrave diet pill, Orexigen Therapeutics has now put further development on hold after receiving an “unprecedented” request for a pre-approval clinical trial that the aspiring drug developer believes “would generate significantly more information than is necessary or feasible.” As a result, Orexigen plans an appeal this month. At issue are concerns over cardiovascular risks that prompted the FDA to request a randomized, double-blind, placebo-controlled trial. In fact, the FDA told Orexigen execs that the agency plans to hold an advisory committee meeting early next year to assess cardiovascular issues with diet drugs, in general. This is only the latest indication the FDA is raising a high ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893913 Fri, 03 Jun 2011 13:28:00 +0100 4893913 http://www.medworm.com/index.php?rid=4566342&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FojH331Zf3Vk%2F Good morning one and all. Nice to see you again. ‘Tis the middle of the week, which means we are in the thick of those meetings and deadlines. To cope - yes - we are brewing some cups of stimulation. Two-fisted drinking is possible even while manipulating a laptop. Feel free to join us. And we would also like to invite you to a webinar we are hosting next week on disclosing physician payments. Meanwhile, here are some interesting tidbits. Have a productive day and stay in touch… Novartis COPD Drug Gets Mixed FDA Panel Verdict (Wall Street Journal) J&J Misled South Carolina About Risperdal, Lawyer Says (Bloomberg News) Combo Diet Pills Making A Comeback (MSNBC) Human Genome Lupus Drug Expected To Be Approved (Reuters) Glaxo Withdraws Sports Drink Over Mold Growth (The Groce... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4566342 Wed, 09 Mar 2011 12:40:08 +0100 4566342 http://www.medworm.com/index.php?rid=4460183&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIscGIZzZVGw%2F For the second time in as many weeks, an aspiring maker of diet pills has cut its workforce in response to a rejection by the FDA. This time, Orexigen Therapeutics has dismissed roughly 40 percent of its staff, or 23 employees. Not huge numbers in the scheme of things, but certainly symbolic of the difficulty a trio of small companies is having as they attempt to win over a safety-conscious FDA. “We continue to believe in the potential of Contrave (its diet drug) and look forward to discussions with the FDA,” Orexigen ceo Mike Narachi says in a statement. “Unfortunately, given the near-term uncertainty of Contrave approval, we felt it prudent to consolidate and focus our resources. We are deeply grateful for the dedication and tremendous effort provided by all of our coll... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4460183 Thu, 10 Feb 2011 13:48:27 +0100 4460183 http://www.medworm.com/index.php?rid=4429068&cid=t_349287_109_f&fid=38951&url=http%3A%2F%2Fcarlatpsychiatry.blogspot.com%2F2011%2F02%2Ffda-rejects-contrave-for-obesity-big.html As you can read from various sources, including the NY Times, the LA Times, and the Washington Post, the FDA has rejected another anti-obesity drug, Contrave, because of concerns that it might cause heart attacks in patients who take it for years.FDA's excessive caution was motivated by its experience having been burned by the Fen-Phen fiasco. This was a weight loss drug widely prescribed in the 90s that was pulled from the market after studies showed it caused fatal lung and heart valve problems.  This new drug, however, is a combination of two medications that have already been widely prescribed and are fairly safe: Wellbutrin and naltrexone. Psychiatrists are familiar with both of them. We prescribe Wellbutrin for depression and smoking cessation, (and off-label for weight loss, fo... The Carlat Psychiatry Blog blogs http://www.medworm.com/rss/comments.php?id=4429068 Wed, 02 Feb 2011 14:31:00 +0100 4429068 http://www.medworm.com/index.php?rid=4424448&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4AV-BeRptIw%2F Once again affirming ongoing safety concerns about the anticipated widespread use of diet pills, the FDA issued a so-called Complete Response Letter for Contrave, a drug developed by Orexigen Therapeutics. The move comes less than two months after an FDA advisory panel recommended the pill for approval, but also voted in favor of requiring additional studies to gauge cardiovascular risks (back story). In disclosing the rejection, Orexigen ceo Michael Narachi disclosed the agency wants the drugmaker to conduct a randomized, double-blind, placebo-controlled trial. “We are surprised and extremely disappointed,” he says in a statement. Had the FDA approved Contrave, the pill would become the first new prescription diet drug to reach US consumers since 1999, when the FDA endorsed Ro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424448 Tue, 01 Feb 2011 13:30:49 +0100 4424448 http://www.medworm.com/index.php?rid=4304879&cid=t_349287_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffda-set-to-approve-new-anti-obesity-drug%2F2011.01.02 The FDA has been tough on diet drugs of late. Three years ago it scuttled an attempt to get the European diet drug rimonabant approved for use in the U.S. More recently it rejected, at least temporarily, applications for Qnexa and Lorcaserin. But that trend may have been reversed last week, when an advisory committee set the stage for possible FDA approval of Orexigen’s investigational diet drug, Contrave. By a 13-7 vote, the committee said in essence that the somewhat modest beneficial effects of the drug outweighed its tendency to increase blood pressure. The FDA will make final decision on the matter by the end of January. It is not required to follow the advice of its advisory committees, but as was the case for the three diet drugs mentioned above,  it usually does. (more…... Better Health blogs http://www.medworm.com/rss/comments.php?id=4304879 Sun, 02 Jan 2011 19:00:19 +0100 4304879 http://www.medworm.com/index.php?rid=4285351&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsM8mIx_spwY%2F After meeting with FDA officials to review the recent rejection of its Lorqess diet pill, Arena Pharmaceuticals now plans to refile its application by the end of 2011. This means, of course, its drug probably not become available until 2012 and, by then, could well be the last of a new round of diet pills to arrive in pharmacies. Hardly a competitive advantage. You may recall that an FDA advisory panel voted 9-to-5 last September not to recommend approval for Lorqess over concerns the drug may cause tumors in rats and efficacy was marginal. Meanwhile, Vivus failed to win agency approval for its Qnexa pill over side effect issues (look here), although the same FDA panel more recently did endorse the Contrave drug from Orexigen Therapeutics (read this). The three-way race is being closely w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4285351 Thu, 23 Dec 2010 14:20:57 +0100 4285351 http://www.medworm.com/index.php?rid=4238145&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGuLviF9y5LA%2F In a surprise move, the FDA’s Endocrinologic and Metabolic Advisory committee voted 13-to-7 to recommend that Orexigen Therapeutics’ Contrave diet pill be allowed on the market. If the agency follows the advice, which is not guaranteed, Contrave would become the first new prescription diet drug to reach US consumers since 1999, when the FDA approved Roche’s Xenical. The panel, however, also voted 11-to-8 that additional studies are needed to ascertain cardiovascular risks. Nonetheless, the recommendation has the potential to drastically change the weight-loss market and, perhaps, put a dent in the burgeoning population of obese people, which has become a public health issue. Despite the clamoring for new diet tools, the same FDA panel earlier this year bounced two other n... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4238145 Tue, 07 Dec 2010 21:49:42 +0100 4238145 http://www.medworm.com/index.php?rid=4225654&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZFTHevu79xk%2F Twice this year, an FDA advisory committee refused to recommend new diet pills for marketing approval. First, Vivus failed to win approval for its Qnexa drug and the same fate then met Arena Pharmaceuticals and its Lorqess med (see here and here). Next Tuesday, however, the third in this controversial trifecta will make an appearance - Orexigen Therapeutics and its Contrave pill. Will the outcome be different? The FDA briefing documents point out some safety issues, but there do not appear to be any great surprises either, suggesting that, well, anything is possible. On one hand, four studies conducted by Orexigen demonstrated that overweight patients lost, on average, 4.2 percent more weight than patients taking a placebo. On the other hand, this falls short of the FDA guideline that ther... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4225654 Fri, 03 Dec 2010 17:47:33 +0100 4225654 http://www.medworm.com/index.php?rid=4119714&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FW3v5dhlNOsg%2F Earlier this year, there was nothing short of hoopla surrounding the notion that a new trio of diet drugs may win FDA approval. Why? Obesity remains a huge health problem (no pun intended) and there hadn’t been a new prescription diet pill since Roche’s Xenical arrived in 1999. And with FDA advisory committee meetings planned, the reasoning went that the agency saw the need for a new therapy. All of which made sense, to a point. But this is an era when the FDA is under pressure to ensure that safety is a high priority. And rightfully so, given recent controversies over manipulation of clinical trial data and side effects surrounding various meds, as well as agency infighting. Diet pills, however, have merited special attention thanks to the 1997 withdrawal of part of Wyeth&#821... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4119714 Fri, 29 Oct 2010 13:09:20 +0100 4119714 http://www.medworm.com/index.php?rid=4055957&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAN4d2O3u9_g%2F The decision late last week by the FDA to encourage Abbott Laboratories to withdraw its Meridia diet pill has obvious implications for other drugmakers seeking approval for obesity drugs. But will those companies gain or lose? The answer will depend on the extent to which the FDA sees the need to offer more options to fight fat while weighing (pun intended) pressing safety concerns. On one hand, there are few options available to overweight Americans: Roche’s Xenical, which is also sold over-the-counter by GlaxoSmithKline as Alli, and phentermine, the surviving half of the infamous fen-phen weight-loss cocktail (the other half, fenfleuramine, along with a chemically related pill were both recalled in 1997 due to serious heart and lung side effects). But these are only modestly effect... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4055957 Mon, 11 Oct 2010 12:53:29 +0100 4055957 http://www.medworm.com/index.php?rid=3976710&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FT-EWnRbXh7I%2F At first blush, diet pills appear to be all the rage these days. There are no fewer than three new obesity drugs that have generated enormous interest - among investors and patients - this year. And for awhile, the anticipation has suggested this troubled market - which has been littered with recalls, litigation and limited effectiveness - may finally generate real progress. Recently, though, there has been as much concern as optimism. Two months ago, an FDA advisory panel voted against marketing approval for Vivus’ Qnexa pill over worries about usage by pregnant women and psychiatric side effects (back story). [Yesterday, another panel couldn't decide whether to yank Abbott Labs' much older Meridia drug, which is linked to cardiovascular risk, or issue stronger warnings]. Today, an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3976710 Thu, 16 Sep 2010 14:00:06 +0100 3976710 http://www.medworm.com/index.php?rid=3929455&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUCck3j0Uy_E%2F For the second time this summer, a Japanese drugmaker has agreed to pay $50 million upfront for the rights to a forthcoming diet pill. This time, Takeda Pharmaceuticals is giving Orexigen Therapeutics $50 million for exclusive North American marketing rights (but co-promotion in the US) for Contrave and another $1 billion for meeting regulatory and sales milestones, along with double-digit royalties (see statement). Just a few weeks ago, Eisai paid $50 million for the rights to sell Arena Pharmaceuticals’ lorcaserin in the US; another $160 million based on development and approval milestones, and a $1.16 billion, one-time payment that may follow based on annual sales. Neither pill has been approved - an FDA advisory panel will review Arena’s lorcaserin on Sept. 16, while Orexigen&... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3929455 Thu, 02 Sep 2010 13:13:44 +0100 3929455 http://www.medworm.com/index.php?rid=3758106&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDjg7tRYJ3HQ%2F What will it take to convince a panel of experts that a diet pill is safe, not just effective? Vivus is the latest company to fail to come up with an answer. An FDA advisory committee today voted 9 to 7 to reject its Qnexa pill, which was effective in clinical trials, but worried panelists about usage by pregnant women and psychiatric side effects. These concerns were raised by agency medical reviewers (look here), given that diet drugs are widely expected to be used on a long-term basis. The outcome contradicts what some Wall Street analysts were cautiously predicting - a vote in favor of recommending approval, albeit with labeling and marketing restrictions, which would have made Qnexa the first new prescription diet pill in more than a decade. However, this has been a three-way race. Tw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3758106 Fri, 16 Jul 2010 02:14:15 +0100 3758106 http://www.medworm.com/index.php?rid=3718693&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuxvU1Buf_Gg%2F More than a decade ago, the fen-phen weight-loss cocktail and a related diet pill called Redux made headlines after links to heart and lung troubles forced a recall, which eventually cost Wyeth $21 billion in charges. Other prescription drugs - Abbott’s Meridia and Roche’s Xenical - never fared well due to side effects. Sanofi-Aventis never sold Acomplia due to psychiatric side effects. And even the over-the-counter Alli pill, which is really a version of Xenical, is suspect these days thanks to concerns over liver injury (see here). Now, though, a trio of would-be diet pill makers is focusing attention anew on the long-disgraced obesity market. This is underscored by Eisai’s willingness to pay $50 million for the rights to sell Arena Pharmaceuticals’ lorcaserin in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718693 Thu, 01 Jul 2010 20:57:20 +0100 3718693 http://www.medworm.com/index.php?rid=3468021&cid=t_349287_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fx5kKBxgumFg%2F Top of the morning to you. Another shiny day here on the Pharmalot corporate campus and our spirits are high. And why not? Once again, we would like to share a favorite saying of the Morning Mayor: ‘Every brand new day should be unwrapped like a precious gift.’ So go ahead and tug on the ribbon. Meanwhile, here are a few items to help you along. Have a great day, everyone… Buy Bullish Dendreon Options Says Analyst (Bloomberg News) Canada Made ‘Value Judgment’ In Dropping HIV Plant (InPharmaTechnologist) Harvard’s Avorn Hires Faculty To Test Comparative Effectiveness (Bloomberg News) Orexigen Revises Obesity Drug Data (Reuters) Sanofi-Aventis Shifts PR Chief To Global Responsibility Role (PR Week) Teva Strikes Deal For Mersana Cancer Drug (PharmaTimes) Me... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3468021 Wed, 14 Apr 2010 11:14:44 +0100 3468021