Contrave Finally Clears FDA

Late yesterday, Contrave became the third new obesity treatment to be approved by FDA in the last two years. All three of these drugs went through FDA advisory committee hearings in 2010. At the time, Contrave was the only one of the three that the expert panels recommended for approval. Yet in 2011, FDA ruled that the Orexigen (the developer of Contrave) would have to submit new data before Contrave could be approved.

It’s a useful reminder that FDA doesn’t always do precisely what its advisory panels recommend.

The question that had to be resolved related to the risk of increased heart rate and blood pressure, which can be the result of taking Contrave. FDA wanted — and now has — some assurance that this risk would not cancel out the benefits of the drug. Interim analysis of an ongoing study showed no increased risk of heart attacks from taking Contrave compared to a placebo. That’s the finding that resolved the question and cleared the way for approval.

Contrave more than doubles the odds that people who take it can lose enough weight (5% or more) to significantly improve their health. It’s a combination of two drugs, bupropion and naltrexone, that have been on the market for other uses for some time. In this sustained-release formulation, they work together to help people achieve and maintain a healthier weight in a way that is different from other currently available obesity treatments.

For treating hypertension, doctors have more than 100 options. For treating obesity, they now have five. Slowly, the options are expanding.

Another option for treating obesity — liraglutide — comes before an FDA advisory panel for a vote today. Stay tuned!

Click here to read more in the New York Times and here to read more from Bloomberg BusinessWeek.

Drake Relays, photograph © Phil Roeder / flickr

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