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Female Viagra Gains Approval From FDA Advisory Committee

Dorathy Gass

A drug being dubbed the ‘female Viagra’, developed to help women who have lost their sex drive, jumped a tremendous hurdle last week when a Food and Drug Administration (FDA) advisory committee voted to recommend approval on the drug. The committee voted 18 to 6 in favor of flibanserin, a pill that aims to boost the sexual drive for premenopausal women. While this does not mean that the FDA has to follow their recommendation, and they still need to approve the drug before sale; advice from the panel is often followed by the FDA when coming to a decision such as this.

According to CNN, Pfizer has earned over $1.6 billion in revenues, since the FDA placed their stamp of approval on Viagra in 1998. Since, drug companies have been scrambling to find the right alternative to provide woman; and have unfortunately been unsuccessful. One-third of adult females do experience a decrease in their sexual desire (according to a 2002 study), and the reasoning behind the development of a treatment for women has been far more complex than the issues around adult males.

“Women’s sexuality is very complicated. It’s not a matter of just taking that pill by the way, and then all of a sudden the lights go on,” said Judy Kuriansky, a clinical psychologist and certified sex therapist. “You have to feel good about your body. You have to feel good about yourself. You have to feel the guy really loves you. … It’s complex. It’s not the same as a man taking a pill.”

So while many are referring the drug as the ‘Viagra for women’, the way the little pill works for females, versus their male counterparts is quite different. While the male version focusses on treating erectile dysfunction; flibanserin works as an antidepressant, focusing on a woman’s central nervous system.

Produced by Sprout Pharmaceuticals, last week’s meeting marked the third time the FDA advisory panel has reviewed the treatment; which had been rejected by the committee in the past as they felt it had a lot of side effects, with little effectiveness to help a woman’s sex drive. In fact, in 2010 a panel advised Boehringer Ingelheim, a pharmaceutical company who had first come up with the drug, to re-visit the concept, as additional conclusive data was needed. It was then rejected in 2013. In 2014 Sprout Pharmaceuticals re-visited the idea, saying it was gearing up to conduct further studies as the FDA had given them ‘clear guidance’ on what sort of path they needed to move forward.

A study published in The Journal of Sexual Medicines in 2013 revealed that the drug increased an average of 2.5 satisfying sexual events in four weeks for women who took it; versus 1.5 for those in the study who took placebo.

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