"Female Viagra" Again Seeks FDA Approval
Arthur Dominic Villasanta | | Feb 17, 2015 11:26 PM EST |
Holding hands
A "sex pill" that increases a woman's desire to have sex has again been sent to the U.S. Food and Drug Administration for approval.
The drug is called flibanserin and its proposed trade name is Girosa. It's basically a female version of Viagra and Cialis.
If approved by the FDA, flibanserin will be the first drug for women that report a lack of sexual desire. Its maker, Sprout Pharmaceuticals, said it's re-filing its application for the drug with the FDA and will add new information requested by the FDA about how the pill affects driving ability.
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And there seems to be a market for a "female Viagra". Sprout cites a 1999 survey in the Journal of the American Medical Association that found 43 percent of U.S. women had some type of sexual dysfunction.
The FDA previously rejected flibanserin because of its lackluster effectiveness and side effects that include fatigue, dizziness and nausea. The drug was rejected by the FDA for the second time due to results showing some 10 percent of women in company trials reported sleepiness as a side effect.
Intense lobbying by women's groups, consumer advocates and politicians aimed at getting the drug on the market has triggered more intense public interest in flibanserin.
Sprout and other pharmaceutical companies have begun saying the lack of a "female Viagra" is a women's rights issue.
"Women deserve equal treatment when it comes to sex," said an online petition to the FDA that got 25,000 supporters.
Last January four members of Congress sent a letter to the FDA urging a careful reassessment of flibanserin. They bewailed the lack of drug options for low female libido.
"There are 24 approved medical treatments for male sexual dysfunction and not one single treatment yet approved for the most common form of female sexual dysfunction," said the letter signed by four Democratic Representatives.
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