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FDA advisory panel approves pill to increase women's libido

"Critics say the improvement might only be modest, but, oh what I would give for even a modest improvement," flibanserin study participant Katherine Campbell said.

By Danielle Haynes and Doug G. Ware
FDA advisory panel approves pill to increase women's libido
An FDA advisory committee gave preliminary approval to a female libido drug. The FDA could give full approval by the end of the summer. Photo by Iurii Kachkovskyi/Shutterstock

WASHINGTON, June 4 (UPI) -- Flibanserin, colloquially known as "Viagra for women," cleared a hurdle Thursday in the process of getting approval by the U.S. Food and Drug Administration -- something the medication has twice failed to do so far.

By a vote of 18-to-6, a federal advisory panel on Thursday recommended flibanserin's approval -- with the condition that it be prescribed to treat a lack of sexual desire in women that is not attributable to non-medical causes.

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The panel's advice was immediately hailed by some women's organizations as a step toward sexual equality. The medication, manufactured by Sprout Pharmaceuticals, still needs to receive actual approval by the FDA.

In contrast to Viagra, which treats male erectile dysfunction, flibanserin targets chemistry in the female brain that is thought to be responsible for sexual desire. The drug, like many, is accompanied by a list of potential side effects like low blood pressure, fainting, nausea and dizziness.

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Approval of the drug has been a cause pushed by equality advocates who view Viagra as the result of gender bias on the part of the FDA -- an accusation agency officials flatly deny. One official cited the fact that no medication has ever been approved for men to treat a lack of sexual desire. Viagra targets erectile dysfunction.

The FDA has denied approval of flibanserin on two prior occasions, the first in 2010 when the advisory panel was unanimous in its decision against the drug. Advocates believe it may finally be approved this time in part due to a much greater public voice asking for the drug.

The FDA, which typically follows the panel's recommendation, has until Aug. 18 to approve the medication.

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However, the panel vote on flibaserin might have been closer than the vote tally indicates, the New York Times reported Thursday. It cites several committee members who said they voted for the drug but had misgivings about potential side effects and the tablet's effectiveness.

"The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point," panel member and drug safety expert Tobias Gerhard said.

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Flibanserin would be approved for premenopausal women whose low sex drive causes them distress, officials said -- a condition called hypoactive sexual desire disorder. Officials said about seven percent of women fall into this category.

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The pill is designed to affect centers in the brain that produce serotonin and dopamine -- two key ingredients that scientists say determines sexual desire.

Critics, though, question whether the FDA is acting responsibly by approving a drug that has so far been shown to have only a minimal positive impact. In tests, women who appeared to respond to the drug reported having just one more "sexually satisfying event" per month than women who took a placebo -- a dummy tablet with no medicinal value.

The two possible side effects the FDA is most concerned about is the risk of lowering blood pressure and fainting spells, the Times report said.

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However, experts say there are many women suffering through no fault of their own. Their decreased sexual appetite, they say, can range from a simple annoyance to a major problem that threatens their self esteem, relationships and even marriages.

"Today is my son's first birthday, and I'm missing it because I am here desperately looking for help to recover what I have lost -- a vital and beautiful part of my marriage," flibanserin study participant Katherine Campbell said. "Critics say the improvement might only be modest, but, oh what I would give for even a modest improvement."

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