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FDA Advisory Panel Approves Flibanserin, Experimental 'Viagra For Women'

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Flibanserin is being hailed as "Viagra for women." The experimental drug – designed for post-menopausal women with low sex drives – has now won approval from an advisory panel for the Food and Drug Administration (FDA).

The FDA previously rejected the female libido pill twice since 2010 over concerns of side effects. In 2005, an advisory committee recommended unanimously against approval. Side effects experienced by some patients included dizziness, fainting and nausea. In their latest finding, the advisory committee voted 18-6 to recommend the FDA give final approval to the drug produced by Sprout Pharmaceutical.

Women taking the drug reported experiencing between one-half and one more satisfying sexual events per month than volunteers taking a placebo. The subjects provided with the drug also had higher levels of sexual satisfaction and desire.

The drug only received a tepid recommendation from the advisory committee. Comments as to its effectiveness included descriptive terms such as "marginal" and "moderate."

The findings aside, the agency sees a large need among the public for a drug to boost female libido. Flibanserin was first tested as an anti-depressant, but trials showed the drug had a positive impact on sexual satisfaction in women who took the drug.

"These are very modest results. But on the other hand, even modest results can make a lot of difference when you're at a certain point in the clinical problem," said Julia Heiman of the Kinsey Institute managed by Indiana University.

Viagra – designed to increase sexual desire and improve performance in men – was introduced into the private market by pharmaceutical giant Pfizer in 1998. However, sexual desire in women has proven to be unresponsive to hormones, alterations in blood flood or other simple triggers.

Side effects of Flibanserin may be compounded when combined with some prescription drugs or alcohol. Alcohol consumption by patients taking the drug was limited to an earlier study of just 25 patients, which included some males participants. If the drug is approved by the FDA, it will likely come with a warning advising patients not to consume alcohol while taking the medicine.

A final decision from the FDA – one way or another – could come in an August announcement. The agency usually follows the recommendations of their advisory committees, although they are under no obligation to follow suit.  

"I want to want my husband, it is that simple. For us, Flibanserin is a relationship-saving and life-changing drug," said trial participant Amanda Parrish from Nashville, Tennessee, speaking to the committee.

Photo: Abd allah Foteih | Flickr

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