Magazine article Clinical Psychiatry News

Physician Certification Recommended for Flibanserin: Drug Would Be First Approval for Hyposexual Desire Disorder in Premenopausal Women

Magazine article Clinical Psychiatry News

Physician Certification Recommended for Flibanserin: Drug Would Be First Approval for Hyposexual Desire Disorder in Premenopausal Women

Article excerpt

FDA advisory panelists voting in favor of flibanserin for hypoactive sexual desire disorder in premenopausal women might not have done so without the option of recommending physician certification as a condition of approval.

At a joint meeting of two Food and Drug Administration advisory panels in June, members of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18-6 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. If approved by the FDA, flibanserin would be the first drug approved for treating HSDD. (The DSM no longer includes HSDD as a separate diagnosis. Instead, it lists female sexual interest/ arousal disorder [FSIAD], which "combines features of HSDD and another condition from the DSM-IV known as female sexual arousal disorder," the FDA pointed out.)

Assurance that prescribers would be fully apprised of the serious risks of hypotension and syncope associated with the drug, exacerbation of those side effects when combined with alcohol or a CYP3A4 inhibitor--and the modest effects over placebo --was cited by several of the panelists who voted in favor of approval.

All of those voting in favor of approval chose the option of supporting approval "only if certain risk management options beyond labeling are implemented." None of the panelists voted for the option of supporting approval with "labeling alone to manage the risks."

The conditions include a risk management plan to address serious adverse effects associated with the drug, a requirement for physician certification, and postmarketing studies to further evaluate and monitor the drug's safety and efficacy.

The risks of hypotension and syncope, and central nervous system depression also are exacerbated by moderate or strong CYP3A4 inhibitors. But the interaction with alcohol was raised as a particularly serious issue because of the high rate of alcohol use and binge drinking among women who would likely be treated with flibanserin, according to FDA reviewers.

The risk of drug interactions can be mitigated with drug interaction screening programs used in health care systems, such as in electronic medical records and pharmacies, while alcohol use is a patient-dependent behavior, is common among women, and therefore more difficult to control, Kimberly Lehrfeld, Pharm. …

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