FDA advisory panel backs Sprout Pharma's flibanserin to boost female libido

The US Food and Drug Administration's joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee yesterday voted 18 to six that the benefit/risk profile of Sprout Pharmaceuticals' flibanserin (proposed trade name Addyi) supports FDA approval for hypoactive sexual desire disorder (HSDD) in premenopausal women, but only if certain risk management options beyond labeling are implemented.

"We are pleased with the positive outcome of today's Advisory Committee meeting and the confidence that was expressed regarding the efficacy and safety of Addyi," said Cindy Whitehead, chief executive of privately-held US sexual health specialists Sprout Pharmaceuticals, adding: "With today's decision, we are one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction. We look forward to continuing our work with the FDA as it completes its review of our new drug application, including the discussion of a Risks Evaluation and Mitigation Strategy (REMS)."

HSDD is the most commonly reported form of female sexual dysfunction. The condition has been medically recognized for more than 40 years and is characterized by a deficiency or absence of sexual fantasies and desire for sexual activity, which causes marked distress or interpersonal difficulty, and is not better accounted for by another disorder or to the effects of a substance. HSDD does not encompass normal (eg, daily or weekly) fluctuations in levels of desire. Around one in three women in the USA suffer from low sexual desire, and one in 10 women (16 million women total) are distressed by it.