FDA panel backs Contrave
SAN DIEGO — A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.
Orexigen Therapeutics and Takeda Pharmaceutical announced Tuesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that clinical trial data demonstrated that the benefits of the drug Contrave (naltrexone and bupropion) outweighed its risk and supported approval. The committee also voted 11-8 to recommend a study to examine Contrave’s effect on risk for cardiac disease.
“We are encouraged by the panel’s view of the risk-benefit profile of Contrave,” Orexigen president and CEO Michael Narachi said. “We look forward to continued discussions with the FDA regarding the design of a post-marketing study to evaluate cardiovascular risk and to address the questions raised at the meeting today in preparation for our [Prescription Drug User Fee Act] action date in January.”
Diet pills for treating overweight and obese patients have been a tough sell for the FDA. The agency declined to approve such drugs as Vivus’ Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’ Lorquess (lorcaserin) while requesting that Abbott’s Meridia (sibutramine) be removed from the market due to safety concerns.