‘Female Viagra’ passed the FDA’s panel deliberation on third try

 

An advisory panel of the FDA recommended the first drug to help fight female sexual dysfunction. Sprout Pharmaceuticals, the owner of the pill, is expectant the agency approval will be given in mid-August.

Last Thursday’s 18-to-6 vote came with a big forewarning, a program is essential to highlight troublesome interactions with other medicines and side effects. But the votes by the panel symbolizes a defining moment in women’s health.

The drug is the focal point of a long-running debate whether female sexual dysfunction is a genuine medical problem, if medicines ought to be used for treatment and the extent of the FDA’s approval for new drugs amid claims of gender bias.

Sprout’s chief executive, Cindy Whitehead said,  “This condition has been mired in a lot of folklore and misconceptions.”

The drug itself is controversial. Flibanserin was twice rejected by the FDA. The first time in 2010, when the agency decided the drug wasn’t sufficiently effective, when Boehringer Ingelheim still owned it. Two years ago, it was rejected again,  after it was determined by FDA that flibanserin exhibited only “modest” benefits in the increase of sexual satisfaction.

Sprout response was to join “Even the Score,” an online movement formed with other drug makers together with consumer advocacy groups, which attempted to pressure the FDA to approve drugs for female sexual dysfunction treatment. The initiative earned supporters in Congress, prompting lawmakers to meet with FDA.

The notion that two dozen medicines to treat male erectile dysfunction were given approval by the agency but no female sexual dysfunction treatment.  FDA noted though, there are presently 21 medicines already approved containing estrogen to treat pain during intercourse and menopausal vaginal dryness. But these problems are not the same as desire, however.

“It’s exciting we’ll have this in our armorarium, but we all wish it was a better drug,” said assistant professor Amy Whitaker at the Department of Obstetrics and Gynecology at the University of Chicago and also a panel member.

“As a feminist, I’m delighted people are taking women’s sexual issues seriously, but recommending approval for this drug isn’t the correct response,” Cindy Pearson,  the National Women’s Health Network executive director, said.  “This sets a low bar.”

Source: http://www.wsj.com/articles/fda-panel-recommends-approval-of-drug-to-help-womens-sex-drive-1433452544

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