FDA Advisory Committee Recommends Sprout Pharmaceuticals’ HSDD Drug

Sprout Pharmaceuticals, a Raleigh, North Carolina-based pharmaceutical company, reports that the US Food and Drug Administration's (FDA) joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee recommended the approval of Sprout Pharmaceuticals' ADDYI (flibanserin) for hypoactive sexual desire disorder (HSDD) in premenopausal women, but only if certain risk management options beyond labeling are implemented.

ADDYI is a non-hormonal drug. It is a multifunctional serotonin agonist antagonist (MSAA) and, if approved, would be the first post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist available to prescribers for the treatment of premenopausal women with HSDD. HSDD is the most commonly reported form of female sexual dysfunction. endation, but it will consider its decision as part of the ADDYI new drug application (NDA) review. If approved, ADDYI will be the first FDA-approved treatment for HSDD.

Source: Sprout Pharmaceuticals

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