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‘Female Viagra’ gets nod from FDA advisory committee

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WASHINGTON — A drug aimed at helping women who’ve lost their sex drive cleared a key hurdle Thursday, winning backing from an FDA panel.

An FDA advisory committee voted 18-6 to recommend that the FDA approve the drug flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

The panel’s recommendation will be given to the Food and Drug Administration, which will ultimately decide whether to approve the drug — dubbed by some as “female Viagra.” The FDA often follows the recommendations made by advisory committees but is not required to do so.

“I am elated, very happy to hear this,” Dr. Margery Gass, a sexual dysfunction expert at Cleveland Clinic, said after Thursday’s vote. “I think women are going to be very appreciative of having something they can try for this problem.”

Thursday’s meeting was the third time the drug, made by Sprout Pharmaceuticals, was reviewed by an FDA advisory committee.

In 2010, a committee told pharmaceutical giant Boehringer Ingelheim, which initially developed the drug, that the company should go back to the drawing board to develop more conclusive data about it. In 2013, the drug was rejected without going before the committee.

Last year, Sprout Pharmaceutical said it was preparing to conduct additional studies after the FDA had given the company “clear guidance” on “the path forward.”

According to a 2002 study, up to one-third of adult women might experience hypoactive sexual desire disorder — the technical term for when women have a lack or absence of sexual desire or fantasy.

A 2013 study in the Journal of Sexual Medicine showed that women taking the drug reported an average increase of 2.5 satisfying sexual events in four weeks, compared with an increase of 1.5 among women using a placebo.

 

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2 comments

  • jimnjoy

    Great. It has lots of dangerous side-effects. I can imagine that the personal injury lawyers are practically salivating as they contemplate the potential law-suits down the line.

    Women want so much to be equal. Their life expectancy used to be way more than men. Now it’s about the same. Welcome to “equality”, ladies.