"Female Viagra" Gets FDA Panel Approval

An FDA advisory committee voted 18 to 6 to recommend approval of flibanserin (Addyi, Sprout Chemicals) to treat hypoactive sexual desire disorder in premenopausal women. The drug is a 5 hydroxytryptamine (5HT) type 1A receptor agonist and 5HT type 2A antagonist, taken in an oral 100 mg dose, once daily at bedtime.

The same advisory panel previously twice rejected flibanserin due to treatment efficacy rates that were similar to placebo and possibly serious side effects.
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In 3 new studies, flibanserin increased satisfying sexual events by 0.5-1 per month or roughly a 10% increase in treatment effect over placebo.

The FDA warned about the drug’s risk for syncope and hypotension, which is further increased with use of CYP3A4 inhibitors (including hormonal contraceptive products) and alcohol.

Reference:

FDA. FDA briefing document: joint meeting of the bone, reproductive and urologic drugs advisory committee (brudac) and the drug safety and risk management (DSARM) advisory committee. June 4, 2015. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM449088.pdf