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Treating Low Sexual Desire With “Female Viagra”

Flibanserin, an antidepressant-like drug, makes sex more satisfying for some premenopausal women distressed over their low sexual desire.

The findings come from phase III clinical trials that drugmaker Boehringer Ingelheim hopes will convince the FDA to approve flibanserin for the treatment of hypoactive sexual desire disorder (HSDD).

While HSDD is a controversial diagnosis — some experts see it as the medicalization of what is for many women a relationship issue — the 1,378 premenopausal women enrolled in the clinical trials were suffering distress over their lack of sexual desire.

Compared to women who received inactive placebo pills, those who took flibanserin at bedtime were more likely to get relief from self-reported sexual distress, to experience more sexual desire, and to have more sexually satisfying experiences.

The drug didn’t work for all women. Just under a third of women taking flibanserin got over their sexual distress and/or lack of sexual desire (vs. about a fifth of women taking placebo pills). But the difference was important to the women, says study researcher Michael L. Krychman, MD, medical director of sexual medicine at Hoag Hospital in Newport Beach, Calif.

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“The absolute number of women who had remission of sexual distress was clinically significant, but equally important to them was how it improved their lives,” Krychman tells WebMD.

Nearly half of women taking flibanserin (and nearly a third of women taking placebo) reported at least minimal improvement in “bothersome decreased sexual desire.”

Flibanserin is taken nightly at bedtime. However, it’s not an on-demand treatment. Data suggest that the drug begins to affect sexual satisfaction after four weeks of continuous treatment.

In the 24-week “Bouquet” studies (each of the Boehringer Ingelheim-funded studies is named after a flower), there were few drug-related side effects. Those most commonly reported were daytime sleepiness, dizziness, fatigue, anxiety, dry mouth, nausea, and insomnia. Some 15% of women on flibanserin, and 7% of those on placebo, stopped treatment due to side effects.

Updated reports on data from the North American “Daisy” and “Violet” studies were made by Krychman and other researchers at this week’s annual meeting of the American College of Obstetricians and Gynecologists in San Francisco.

Kychman is an advisor to Boehringer Ingelheim and serves on their speakers’ bureau, services for which he is compensated.

Filbanserin’s Effect on the Brain

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In mid-June, an expert advisory panel will vote on whether to recommend FDA approval of flibanserin. But Boehringer Ingelheim isn’t waiting for FDA approval to begin its marketing campaign, although the materials are careful not to mention the drug. Information on company-sponsored web sites emphasize the “sex/brain/body” connection: that is, that “the brain is the most important sexual organ.”

Flibanserin acts on the brain. It is not a hormonal treatment, such as the Intrinsa testosterone patch (approved in Europe but not in the U.S.). And despite being dubbed “female Viagra” in the media, it has nothing in common with Viagra or other erection enhancers.

Flibanserin was designed as a treatment for depression. Like the SSRI class of antidepressants, it affects levels of serotonin and other chemicals in the brain. But exactly how flibanserin affects sexuality remains unknown.

 

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