Results Wire: US FDA Advisory Committee Supports Sprout Pharmaceuticals’ Addyi (Flibanserin) For Hypoactive Sexual Desire Disorder, But With Added Measures To Mitigate Risk – JUN 4, 2015 (BRUDAC-DSRM)
On Thursday, June 4, 2015, the Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) jointly supported approval of Addyi (flibanserin 100 mg tablets) by Sprout Pharmaceuticals Inc. (Sprout) for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. In particular, 18 members voted “Yes, but only if certain risk management options beyond labeling are implemented.” Six members voted “No.” There were no votes for the other option, “Yes, with labeling alone to manage the risks.”