FDA Approval For Flibanserin ‘Female Viagra’ Could Be Coming Soon

The FDA’s approval for flibanserin, also known by the nickname “female Viagra,” could be coming soon.

According to News Max Health, the U.S. Food and Drug Administration could very well be on their way to approving the controversial drug that is said to be used to boost libido in women. Flibanserin, made by Sprout Pharmaceuticals, could be a new option for millions of women who suffer from hypoactive sexual desire disorder.

“This would bring another option to the table that doesn’t currently exist,” Fred Wyand, the spokesman for the American Sexual Health Association, said. “There really are not any medical options available for women who have low sexual desire. There just aren’t a lot of choices out there.” The American Sexual Health Association is a group that testified at a FDA hearing in favor of flibanserin.

According to HSDDOnline, hypoactive sexual desire disorder is “characterized as a lack (or absence) of sexual fantasies and desire for sexual activity, which lasts for some period of time.” While sometimes the cause of HSDD is unknown, there are several factors that can contribute to a woman developing the disorder: various health/medical problems, drug interactions, psychiatric problems, low levels of testosterone, or high levels of prolactine.

The road to approval has been quite rocky, with the FDA already turning down the drug on two separate occasions; once in 2010 and then again in 2013. In June, the FDA advisory board voted 18 to 6 to recommend the approval, but so far, nothing has come of it. However, that could soon change.

Keesha Ewers, founder and chief medical officer of the Functional Sexology Institute, said the drug hasn’t shown to be very effective. The women who participated in the clinical trials only reported “an increase of one additional satisfying sexual event per month.” Ewers added that it also “doesn’t appear to directly boost a woman’s libido.”

“Not one person in the studies that have been done has actually reported an increase in sexual desire,” Ewers said. “What has been reported is a decrease in the distress that is felt about lack of sexual desire.” There have also been several safety concerns regarding flibanserin side effects, including sleepiness, dizziness, fainting, fatigue and nausea, according to the Washington Post.

In June 2014, the “Even the Score” campaign was launched, which argues gender-rights as a reason to approve the drug. The FDA has reportedly approved 26 drugs to treat sexual dysfunction for men and none for women

“We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women,” NOW President Terry O’Neill said in an interview with NPR earlier this year. “And, I fear that it’s that cultural attitude that men’s sexual health is extremely important, but women’s sexual health is not so important. That’s the cultural attitude that I want to be sure the FDA has not, maybe unconsciously, imported into its deliberative process.”

The campaign created a petition on Change.org requesting the FDA approve flibanserin in June, and received over 60,000 signatures. A similar campaign asking the FDA to reject the drug only gained 652 supporters.

Do you think the FDA should approve flibanserin? Leave your comments below.

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