Orexigen falls on Contrave update

Orexigen Therapeutics Inc. (NASDAQ:OREX) lost $1.06 (33%) to $2.12 on Friday after suspending all of its obesity programs in the U.S. following FDA's request for a larger-than-expected cardiovascular outcomes trial prior to approval of Contrave. Orexigen will appeal the request, which FDA's Division of Metabolic and Endocrinologic Products made 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. ...