FDA panel backs flibanserin approval with risk-mitigating plans

FDA's Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees voted 18-6 that the benefit/risk profile of flibanserin from Sprout Pharmaceuticals Inc. (Raleigh, N.C.) supports its approval to treat hypoactive sexual desire disorder (HSDD) in premenopausal women -- but only with risk management plans. No committee members voted that labeling alone would effectively manage risks. Flibanserin's PDUFA date is Aug. 18.

Several committee members who supported approval of the serotonin (5-HT1A) receptor agonist and serotonin (5-HT2A) receptor antagonist said they did so with reservations. Some said the fact that there are no approved treatments for HSDD influenced their votes. Many supported implementation of a REMS, suggested prescriber certification and supported post-approval studies to better define risks associated with alcohol use and pregnancy. ...