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Posted at 5:37 PM ET, 12/ 7/2010

FDA advisers endorse weight-loss drug

By Rob Stein

A federal advisory panel Tuesday endorsed a new weight-loss drug, potentially breaking a string of disappointments in the effort to find the first new pharmacological weapon to fight the obesity epidemic in more than a decade.

The Food and Drug Administration advisory panel voted 13-7 that the available evidence indicates that the potential benefits of the drug Contrave outweigh its risks.



Contrave tablet (Orexigen)

Contrave, which is made by Orexigen Therapeutics Inc. of La Jolla, Calif., is a combination of naltrexone, which is used to treat alcohol and drug addiction, and buproprion, which is sold as Wellbutrin when used as an antidepressant and Zyban when used to help people quit smoking.

The drug helped patients who took it for a year lose between 4 percent and 5 percent more weight than those who took a placebo, the FDA concluded in a review of studies testing the drug. But the drug also increased blood pressure and heart rate, raising fears that it may boost the risk for heart problems, a major concern that has dogged the development of weight-loss drugs. The studies were too short to know whether the drug actually increased the risk for heart attacks or stroke.

Many of the committee members expressed deep concerns about the drug's possible risks, including seizures. But the committee voted 11-8 (with one abstention) that a large study looking at whether Contrave increases the risks of cardiovascular problems could be done after approval.

The FDA is not required to follow the panel's recommendation, but the agency usually does. A decision is expected by January.

The recommendation is the third weight-loss to come before the FDA for approval in recent months. The agency rejected the two previous drugs--lorcaserin and Qnexa--after advisory panels recommended against their approval because of safety concerns.

In October. the drug diet-drug Meridia, which was originally approved in 1997, was pulled from the market at the request of the agency because of concerns about the risk of heart problems. Only a handful of government-approved weight-loss drugs remain on the market and only one, Orlistat, can be used long term.

Some consumer advocates oppose Contrave's approval, citing the possible risks and modest possible benefits. But some obesity experts argue that the FDA is holding weight-loss drugs to too high a standard. The agency should be willing to approve some new agents even if they carry some risks--the same bar medications to treat diabetes and other chronic diseases must pass, they argue.

The FDA has not approved a new weight-loss drug since 1999, when Orlistat was authorized. But Orlistat is not very effective and can cause unpleasant side effects, most notably diarrhea.

Another FDA advisory panel last week did recommend the agency allow slightly less obese patients undergo a surgical procedure to implant the Lap-Band device to help them lose weight.

By Rob Stein  | December 7, 2010; 5:37 PM ET
Categories:  FDA, Obesity  
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Comments

" But the committee voted 11-8 (with one abstention) that a large study looking at whether Contrave increases the risks of cardiovascular problems could be done after approval."

This is exactly what is wrong with the FDA! Use the unsuspecting public as guinea pigs and then issue a black box warning or pull it off the market when people start dying.

Posted by: Dipsy1 | December 7, 2010 7:11 PM | Report abuse

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Posted by: zhengee25 | December 7, 2010 8:22 PM | Report abuse

5% more loss. Good, so McDonalds` patrons come out first and only, say, 45 pounds overweight. Let`s try self discipline and sensible diet.

Posted by: nanonano1 | December 7, 2010 8:27 PM | Report abuse

5% more loss. Good, so McDonalds` patrons come out first and only, say, 45 pounds overweight. Let`s try self discipline and sensible diet.

Posted by: nanonano1 | December 7, 2010 8:27 PM | Report abuse

Orexigen Therapeutics Inc. stock jumped 155% in after-hours trading. There must be some great partying going on tonight at their offices.

Posted by: leftcoast1 | December 7, 2010 9:12 PM | Report abuse

and in a year or two after several deaths and additional studies, this drug will be pulled from the shelves. too bad for those experimented on...

Posted by: mycomment | December 7, 2010 9:37 PM | Report abuse

My brother had recommended "Hypersonic Weight Loss" to me. I’ve lost over 100 pounds in 5 months and am still going.

Posted by: antoniarosado | December 8, 2010 12:06 AM | Report abuse

Lorquess and Meridia were recently pulled for damaging health effects. Is it really worth the risk? There is an interesting article at the Health Journal Club that makes the case that the healthiest thing to do is simply not eat anything that wasn't a food 100 years ago.
http://healthjournalclub.blogspot.com/2010/01/100-year-diet.html
Certainly gets rid of the trans fats, artificial food colors, bleached flour, transgenic frankenfoods etc, likely would lead to healthy weight loss as well.

Posted by: LincolnsWisdom | December 9, 2010 3:55 PM | Report abuse

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