Orexigen Weight-Loss Drug Contrave Wins Advisory Panel Recommendation

Orexigen Therapeutics has bucked the recent negative trend among prescription weight-loss drugs with an FDA advisory committee recommending approval for Contrave. The agency’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13–7 Tuesday that the potential benefits of Contrave (naltrexone SR/bupropion SR) outweighed any potential risks associated with the drug. While FDA staff indicated that an approval of the drug would almost certainly come with a requirement that Orexigen conduct an additional safety study, the advisory committee voted 11–8 that such a trial could be conducted after Contrave is on the market.
Drug Industry Daily