Contrave, which is a combination of two drugs already on the market, addiction-treating naltrexone and the antidepressant bupropion, commonly known by the brand name Wellbutrin.
Orexigen argued that Contrave's ingredients have been on the market for 20 years and haven't shown major cardiovascular-safety problems.
Leerink Swann analyst Joshua Schimmer said Orexigen's "conservative presentation seems to have cracked the code." Showing that the panel could be swayed by a thorough risk-mitigation strategy, Orexigen may have also opened some doors for its competitors. In October, the FDA said Vivus needed to provide evidence that its proposed weight-loss drug Qnexa didn't increase the risk of major adverse cardiovascular events before the agency would consider whether to approve the drug. The agency didn't request another clinical study, and Vivus had to meet the FDA's needs by next 3 months.