Magazine article Clinical Psychiatry News

FDA Decision on Flibanserin Expected by August

Magazine article Clinical Psychiatry News

FDA Decision on Flibanserin Expected by August

Article excerpt

AT AN FDA ADVISORY COMMITTEE MEETING

SILVER SPRING, MD. -- The majority of two Food and Drug Administration advisory panels has supported the approval of flibanserin, an oral, centrally acting, nonhormonal drug taken once a day for treating hypoactive sexual desire disorder in premenopausal women. The FDA usually follows the recommendations of its advisory panels, and a decision is expected by August 2015.

Among the conditions recommended by the panels are a requirement for physician certification (see article on page 1). But the panels also recommended some conditions, a risk management plan to address serious adverse effects associated with the drug, and postmarketing studies to further evaluate and monitor the drug's safety and efficacy.

At a joint meeting of two FDA advisory panels, members of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18 to 6 that the overall benefit-risk profile of flibanserin supported approval for treating hypoactive sexual desire disorder (HSDD) in premenopausal women, provided that certain risk management options beyond labeling were implemented. (The DSM-5 does not include HSDD as a separate diagnosis).

No panelist voted for the option of approval with labeling alone to manage the risks of the drug. The main safety issues raised by the FDA were the risks of hypotension and syncope--effects associated with the drug alone and exacerbated by alcohol and by coadministration with CYP3A4 inhibitors.

Those in favor of approval said the drug had only a modest beneficial effect in a controlled, limited population, but cited the unmet need for a treatment for HSDD. Those panelists strongly supported certification of prescribers.

Several panelists said that alcohol should be contraindicated in women taking the drug and that an alcohol interaction study should be conducted in women only. The manufacturer, Sprout Pharmaceuticals, conducted such a study but enrolled 23 men and only two women.

Flibanserin is a "postsynaptic 5-HT1A agonist 5-HT2A antagonist," a nonhormonal treatment with sedating effects; the recommended dose is 100 mg taken every day at bedtime. It is mainly metabolized by CYP3A4.

In three phase III 24-week North American studies, women treated with flibanserin had significant improvements in the number of satisfying sexual events (SSEs) per month and sexual desire from baseline. …

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