FDA Experts Recommend Approval for New Obesity Treatment

The FDA Endocrine and Metabolic Drugs Advisory committee voted 13-7 today in favor of approving a new combination product, Contrave, for the treatment of obesity by prescription. Contrave is a combination of two drugs available for other indications, buproprion and naltrexone.

This decision contrasts sharply with the outcome of three prior meetings this year of the same committee considering treatments for obesity. In those meetings, two other new products, Qnexa  (phentermine/topiramate) and Lorqess (lorcaserin) were voted down. Meridia (sibutramine), a prescription product first approved by FDA in 1998, was voted off the market by the same committee in September.

Advocacy groups testified in the public hearing that the FDA is setting the bar too high for new obesity treatment. “This panel has voted against every obesity treatment that has come before it this year,” said Ted Kyle. “I ask you to take the disease seriously and take the benefits of treatment seriously.” For more on this story, see http://prescriptions.blogs.nytimes.com/2010/12/07/f-d-a-panel-backs-new-diet-pill/