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Orexigen Resubmits Weight Management Drug Contrave to the FDA

On December 11, Orexigen announced the resubmission of its weight management drug Contrave (naltrexone/bupropion) to the FDA. The company has previously stated that it expects the FDA to make a decision by June 2014. Overseas, Orexigen just submitted Contrave to the European Medicine Agency this past October.

In previous trials, participants using Contrave averaged about 5% greater weight loss over one year than those using a placebo (a pill with no medication). People taking Contrave experienced slight increases in heart rate and blood pressure when compared to placebo. Concerns over these cardiovascular side effects led the FDA to delay approval for Contrave in 2011 while it awaited more data, which has now been shared. Orexigen is currently conducting a cardiovascular outcomes study with about 9,000 patients to assess whether there is any increased risk of cardiovascular events (e.g., stroke, heart attack, death from cardiovascular causes) associated with Contrave. To learn more about the study, please read our new now next here.

If approved, Contrave would be the third obesity medication that would become available in the US, following a 13-year period of no FDA approvals of obesity drugs. Arena/Eisai’s weight management drug Belviq launched in the US in June 2013 and Vivus’ obesity drug Qsymia launched in September 2013. Aside from weight loss, Qsymia and Belviq have also demonstrated potential to help improve diabetes control, and in the case of Qsymia, to reduce the progression to type 2 diabetes in high-risk individuals. The obesity field has seen some real improvements on the reimbursement side, meaning patients will need to pay less out of pocket to use these drugs (learn more here). Broadly speaking, 5% weight loss may not sound like much, but we know that there are some patients that are “super-responders” and have excellent results after taking the drug. –NL/HD

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