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Posted at 8:46 AM ET, 02/ 1/2011

FDA rejects another diet pill

By Rob Stein

The federal government has rejected yet another new weight-loss drug.

The Food and Drug Administration notified Orexigen Therapeutics of San Diego that it would not authorize the sale of the drug Contrave, according to a statement released Tuesday by the company.

The FDA "noted concern about the cardiovascular safety profile" of the drug when used "long-term in a popularion of overweight and obese subjects," the company said. The agency said the drug could not be approved before the company conducted a study big enough and long enough to show that the risks do not outweigh the benefits.

The decision comes as somewhat of a surprise. An FDA advisory panel in December endorsed the drug's approval, 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.

"We are surprised and extremely disappointed with the agency's request in light of the extensive discussion and resulting vote on this topic at the December 7 advisory committee meeting," Orexigen President and chief executive Michael Narachi said in a statement. "We plan to work closely with the agency to gain more information to determine the appropriate next steps regarding the Contrave application."

Contrave 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 might 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 committee members expressed concern 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.

Contrave was the third weight-loss drug 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 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.

By Rob Stein  | February 1, 2011; 8:46 AM ET
Categories:  FDA, Obesity  
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Comments

Controlling weight and dieting is hard work. Currently, drugs are not the solution. Tools to help individuals understand and help manage food cravings can help dieters become aware of previously unrecognized patterns enabling individuals to act in a new manner. Products like "MyHealthTrends for Weight Control" and others can help avoid empty and unnecessary calories. It's a good, essential first step to changing one's behavior--which is the key to long-term, sustained weight loss.

Posted by: lee_smith | February 2, 2011 9:19 AM | Report abuse

The target market for weight loss drugs should be the obese. Going from 130 to 115 or 200 to 185 is not for drugs. Going from 280 to 180, or 190 to 125 is for drugs. An extra 4-5% from the placebo group isn't enough, in my mind, to justify any money out of my pocket much less an increased risk of heart problems. Granted, you're already in a high-risk group, but not for the gains cited.

That said, the FDA is so gun shy right now they'd quibble about approving a drug that resurrected the dead a million times out of a million. The Republicans talk about freezing spending at 2008 levels, well the FDA is doing their best to freeze medical technology levels.

Posted by: caribis | February 2, 2011 2:35 PM | Report abuse

What's the deal? The government subsidizes the manufacture of non-nutritious, fat-and-sugar-loaded, empty-calorie foods, and then nixes the production of every new weight loss drug that comes along. Do they WANT us all to be morbidly obese? How's that going to help with our national health care costs?

Posted by: nan_lynn | February 2, 2011 11:32 PM | Report abuse

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