Pill to Treat Low Sexual Desire in Women Rejected by U.S. Regulators

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Sprout Pharmaceuticals, Inc., which is based in Raleigh, North Carolina, is seeking approval of the therapy known as Flibanserin, as an option for women whose low libido causes stress in their lives. The medicine, a pill, Flibanserin, which would be used to treat low sexual desire in women, was rejected by U.S. regulators, a decision that has been appealed by the drug’s maker in a bid to make it the first product for the disorder on the market.

About 43 percent of women experience some sort of sexual dysfunction and one in 10 women have low desire with accompanying distress.

  

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Bloomberg reports that according to Sprout, Flibanserin, if approved, would treat a sexual disorder known as female hypoactive sexual desire disorder, which is low libido that causes stress.

The treatments for women’s sexual dysfunction have lagged behind those for men in the 15 years since Pfizer Inc. (PFE)’s Viagra was approved for erectile dysfunction. Pfizer gave up studying Viagra for women in 2004. Treatment for men has since grown into a $4.4 billion market in 2012, according to data compiled by Bloomberg. The FDA identified female sexual dysfunction as one of the conditions the agency has selected as part of an effort to stress the perspective of patients in drug development.

Reported as a unanimous decision, an 11-person Food and Drug Administration committee voted against approval of Flibanserin on 18 June. US regulators ruled the controversial drug was little better than placebo for women with low libido.

Committee members reported to US media that they were unconvinced the drug had clinically meaningful benefits as a treatment for hypoactive sexual desire disorder in women. There were also other concerns about Flibanserin’s significant side effects and interactions with other drugs.

Image Credit: time.com, smh.com.au