Contrave regulatory update

Orexigen suspended all of its obesity programs in the U.S. while it appeals FDA's request for a larger-than-expected cardiovascular outcomes trial prior to approval of Contrave. FDA's Division of Metabolic and Endocrinologic Products made the request in a recent meeting with the biotech to discuss a January complete response letter for the fixed-dose combination of naltrexone and bupropion.

Orexigen said it would need to enroll 60,000-100,000 patients to be able to satisfy the agency's request that the trial show an observed hazard ratio that is "close to or below one." Orexigen had submitted a plan for a trial in 12,000-15,000 patients. The company plans to submit its appeal this month, after which FDA has 30 days to respond. ...