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FDA Will Consider Approval of 'Female Viagra'

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AOL: The little blue pill, responsible for revving up millions of male sex drives, might soon have a female counterpart. But when it comes to a carnal cure for women, "the brain is the most important sexual organ."

female viagra

At least, that's the marketing strategy behind flibanserin, a drug designed to boost lagging sex drives among premenopausal women. The drug will soon be considered for approval by the Food and Drug Administration, although questions linger over how it has been tested, and whether the illness it treats is even credible.

German company Boehringer Ingelheim, which created the drug, wants to see flibanserin available by prescription for women suffering from hypoactive sexual desire disorder (HSDD), a psychiatric condition characterized by a lagging sex drive.

"We believe women deserve options," Michael Sand, a clinical researcher with the company, told The Washington Post, "and we're hoping flibanserin may represent a safe and effective option for many women."

In trials, women diagnosed with low sex drive took 100 milligrams of flibanserin at bedtime every day. Around a third of those taking the drug experienced an improvement in their sex life, according to a survey of 1,330 participants. The survey was funded by the company and released by the American Congress of Obstetricians and Gynecologists.

But some wonder whether HSDD is even an illness. They accuse the pharmaceutical industry -- especially Boehringer Ingelheim -- for creating an ailment just to earn a profit. The company has also sponsored every major study on the efficacy of the drug, spurring questions about the reliability of that research.

"Is it really a problem? Or is it the societal message of what they're supposed to be experiencing, or pressure from a partner or changes in themselves?" Susan Bennett, an assistant professor of medicine at Harvard Medical School, asked in the Post's story.

The pursuit of a female version of Viagra, the popular men's drug that works by increasing blood flow to stimulate an erection, has been unsuccessful thus far. That's largely because, as pharmaceutical companies soon discovered, a woman's sex drive is much more complex.

Flibanserin, first developed as an antidepressant, works by targeting brain chemicals, especially those linked to pleasure and stress. The process is thought to boost a woman's capacity for sexual desire and fantasy -- but even the company behind Flibanserin isn't exactly sure how it works.

"Because flibanserin is a brain drug, they keep harping on this brain thing as if we understood the neuroscience of sexuality, which we don't. This is mythical science," Dr. Leonard Tiefer, a sex therapist and clinical psychologist, told WebMD. "It is a drug that affects serotonin fiddling around in the brain, but where? They have no idea."

Critics are also concerned that the drug might soften the effects of serious relationship problems, especially abuse, that can curb a woman's sex drive.

The FDA doesn't comment on drugs undergoing consideration for approval, but the agency's Reproductive Health Drugs Advisory Committee will convene next month to discuss whether the agency ought to endorse flibanserin.

Whatever the FDA's decision, the long-term side effects of flibanserin won't be known for decades. And after millions of women were stunned by the implications of hormone replacement therapy, Boehringer Ingelheim's road to public approval might be a bumpy one.

In the company's latest clinical trial, around 15 percent of women taking the drug stopped due to acute side effects, which include nausea, headaches, dizziness and insomnia.

Read more stories in the news.

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