While an FDA panel recommended approval of Sprout Pharmaceuticals Inc.’s female sexual dysfunction drug Addyi (flibanserin), several members conditioned their vote on a labeling contraindication and a Risk Evaluation and Mitigation Strategy, despite uncertainties that either would be able to prevent the alcohol use that exacerbates adverse events.
At a joint June 4 meeting, FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-6 in favor of approval of flibanserin for the treatment of female hypoactive sexual desire disorder (HSDD) in premenopausal women