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Sprout's Flibanserin Gets Reluctant Nod From FDA Panel, But REMS Needed

05 Jun 2015

Advisory committee votes 18-6 to recommend approval of the female sexual dysfunction drug contingent on a risk management plan, despite unease about modest efficacy and risks such as fainting.

An FDA advisory committee recommended approval of Sprout Pharmaceuticals Inc.’s Addyi (flibanserin) for treatment of female hypoactive sexual desire disorder (HSDD) despite reservations about the drug’s minimal clinical effect and risks of hypotension and syncope.

At a June 4 meeting, members of FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk...