By Janet Fang
Posting in Food
The FDA rejects Orexigen's Contrave, saying the benefits don't outweigh the heart risks. This is the third weight-loss drug denial in 4 months, casting a cloud over diet pill development.
Contrave from Orexigen Therapeutics and partner Takeda Pharmaceutical was denied approval over its potential heart risks. Had it been approved, it would be the first new prescription diet pill in more than 10 years.
The drug now joins Arena Pharmaceuticals' lorcaserin and Vivus' Qnexa – which were both turned down in October. But unlike the other two, Contrave was endorsed by a panel of expert advisers in December.
This prompted Forbes’ The Medicine Show to write: “the field of obesity drugs is effectively dead... The clear lesson is that weight-loss medicines simply do not have enough of a benefit to justify any risk – and that this makes getting them approved just about impossible."
Contrave tablets are supposed to boost metabolism while curbing appetite and cravings – by combining the anti-addiction drug naltrexone with antidepressant bupropion. It was submitted for regulatory approval in March 2010 based on multiple clinical trials involving more than 4500 people.
About 35% of those patients with obesity lost at least 5% of their starting weight within one year, but they also experienced increased blood pressure and pulse rates [Reuters].
"We are surprised and extremely disappointed…" says Orexigen president and CEO, Michael Narachi, who wishes to work with the FDA on “next steps.”
These next steps include a large clinical study on its cardiovascular risks. The letter from the FDA specified: “before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."
This could take up to 6 years and $200 million.
Obesity is widespread and a risk factor for many serious health issues, but the FDA has shown a high bar for drugs that would be taken indefinitely by millions of patients, many of whom don't have any current health problems.
Past failures – including the fen-phen combination that led to heart-valve problems in some patients – serve as a reminder that safety is the primary concern at the agency.
Abbott Laboratories removed its weight-loss drug Meridia from the market last year under FDA pressure, with the agency saying the "very modest weight loss" from taking Meridia didn't justify its cardiovascular risk.
Shares of Orexigen traded down 71% to $2.62 from Monday's close of $9.09, and the move has erased more than $300 million in market value from the stock.
Image: pills by e-MagineArt.com via Flickr
Feb 1, 2011
Good for the FDA. It's about time we stop turning towards pills to solve our obesity problem. The medical world today seems to be revolving around the "pill for every ill mentality," Maybe doctors should stop prescribing patients pills for obesity and instead PRESCRIBING a basket of fruits and vegetables a day. Instead of going to the drug store and paying $25 for medicine, maybe they should head to the supermarket and buy some fruits and vegetables instead! The food supply in this country is a joke and now pharmaceutical companies are making money off of it. We need to start turning away from drugs for high blood pressure and obesity and turning back towards whole foods. The solution is nutrition.! I write about the nutrition crisis in America on my blog at http://www.nutritionisthesolution.com check it out! Thanks for this post by the way, Laurence :)
It is good to see the FDA protecting us from sliding further down the pill for every problem slope. Most weight issues are behavioral based, so unless you can force people to take a pill to suppress those issues you are not going see much of an impact from these drugs even if they do work. It is well proven you cannot force a psychopath to take medication to cure their problems.
The name "Doctor No" would seem to fit the FDA well. Sometime "no" is the right answer. However, there are surely cases where they are a bit overprotective. When it is truly protective of health, that's fine. If it is protective of their practices and profits, that is a problem. Take a look at happened with product approval of MelaFind (MELA).
This was the comment I posted to Matthew Herper of Forbes regarding his assertion that the obesity drug field is "dead": I find it remarkable today, especially in the world if finance and investing, which is the perspective from which Forbes analyzes the world, that short-sightedness is so prevalent and obvious. The FDA rejection of Orexigen?s Contrave, despite the December 2010 panel recommendation, does indeed represent (at least) the third blow to obesity drugs to have occurred in 2010. But, to make the leap of judgment that the obesity drug market is ?dead?? There are currently no fewer than seven (7)obesity drugs on the market internationally, thirteen (13) drugs in preclinicals/Phase I trials, three (3) drugs in Phase II trials, and two drugs in Phase III trials, if you exclude Contrave, which Orexigen CERTAINLY does not intend to give up on. To conclude that because three drugs have run into regulatory challenges, while ignoring both the number of drugs still under evaluation and the latent (read ?huge?) demand for a drug alternative to surgery or device interventions reflects more of a need for headlines than legitimate consideration of the facts (or the interests of those rare, long-term oriented investors). And who gives a whit that ?Contrave and Qnexa are not even really entirely new drugs?? Name one investor who wouldn?t want to have a share of even a handful of the drugs that have become blockbusters for indications they were never intended. Perhaps you?ve heard of viagra or minoxidil? I applaud you for your headline-making, but I recommend you go back and do a bit more research on the future pipeline and likely investment/development activity in obesity drugs before you declare this patient ?dead?.