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'Female Viagra' Is Rejected by FDA Panel

Advisory Committee Opposes Approval of Filbanserin to Treat Low Sexual Desire in Women
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WebMD Health News
Reviewed by Laura J. Martin, MD

June 18, 2010 -- An FDA advisory panel unanimously rejected what some had hoped would become the first drug approved to boost sexual desire in women.

Experts said the drug, widely dubbed "female Viagra," showed little evidence of working and raised safety concerns. If the FDA follows the recommendation of the advisory panel, it would send drugmakers back to the lab in their quest to come up with a drug that could be marketed to women with lower-than-desired libidos.

German drugmaker Boehringer Ingelheim had hoped to sell the drug, known as flibanserin, as the first medication targeting low sexual desire in premenopausal women. They pointed to studies showing that women who took the drug reported slightly increased feelings of sexual desire and more satisfying sexual episodes than women who took a placebo.

But experts were unconvinced that the increases were clinically meaningful.

"This is not an effective drug," said Bryce Reeve, PhD, program director of the Outcomes Research Branch at the National Cancer Institute and a member of the advisory committee.

Experts were also troubled that the company abandoned part way through its study the scale it used to measure women's experience after less than promising results.

"This would be highly inappropriate," said Scott Emerson, MD, a professor of biostatistics at the University of Washington and a member of the advisory panel.

Flibanserin has been widely touted as the "female Viagra," though the moniker is not quite accurate. Unlike male erectile dysfunction drugs, which are taken minutes or hours before desired sexual activity, flibanserin is taken once a day. And while Viagra and similar drugs work directly on the physiology of the penis and do not increase actual sexual desire, flibanserin acts on the central nervous system, presumably in the pleasure centers of the brain.

Still, that has not stopped drugmakers from pursuing Viagra-like blockbuster status for a similar drug for women. In this case, Boehringer Ingelheim wanted to sell flibanserin to treat hyposexual desire disorder, or HSDD.

Debate Over Hyposexual Desire Disorder

Estimates suggest more than 6% of women between 30 and 39 years of age have HSDD. Numbers climb as women age and reach menopause.

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