independent

Sunday 20 April 2014

Setback for female Viagra as one in 10 women 'get sleepy'

Women's Viagra setback - 10% "get sleepy"
Women's Viagra setback - 10% "get sleepy"

THE search for a female version of Viagra was given a setback when the US drugmaker working to develop the pill to boost sexual desire in women was asked to conduct more studies on the experimental drug.

Sprout Pharmaceuticals revealed that the Food and Drug Administration (FDA) wants to see more data on how the company's drug, flibanserin, interacts with other medications and how it affects driving ability. Nearly 10pc of women reported sleepiness while taking the daily pill.

The FDA's request represents another hurdle in the pharmaceutical industry's 15-year search for a female Viagra.

But in a news release, Sprout Pharmaceuticals President Cindy Whitehead described the development as a "significant step toward the approval of flibanserin". The three studies requested by the FDA are relatively small, involving 25 to 50 patients each. The company says it plans to resubmit its drug application to the FDA during the summer.

The company said in December that it had reached an "impasse" with regulators after the agency issued a second rejection letter on the drug. The company filed a formal dispute over the agency's decision, which prompted the FDA's latest request for additional studies.

If approved, Sprout's daily pill would be the first drug for women who report a lack of sexual desire, a market that drugmakers have been trying to tap into since the blockbuster success of Viagra for men in the late 1990s. While earlier drugs worked on hormone levels, flibanserin is the first attempt to increase sexual desire by acting on brain chemicals that affect appetite and mood.

The race to develop a female libido booster was once dominated by multinational companies like Viagra-maker Pfizer Inc and Procter & Gamble, but today the space mainly consists of tiny startups. Sprout Pharmaceuticals, led by a husband and wife team, acquired flibanserin from Boehringer Ingelheim in 2011, after the German conglomerate abandoned development following an FDA rejection letter. Boehringer studies showed that women taking the drug reported only a modest uptick in "sexually satisfying events."

Irish Independent

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