FDA Approves First Drug to Boost Women’s Sex Drive
After two rejections and years of back and forth over its real benefits, the FDA on Tuesday approved the first medication designed to help women distressed about their lack of libido.
Flibanserin, which will be sold as Addyi, has a checkered regulatory history. In 2009, an FDA advisory committee unanimously voted against approval, because key clinical trials failed to show that it was significantly better than a placebo at improving women’s sexual desire. The FDA followed the panel’s advice and turned down the drug in 2010.
Drugmaker Sprout Pharmaceuticals reapplied to the FDA in 2013 with results from a new clinical trial, but the agency again rejected it. That spurred the company to help launch a campaign called “Even the Score” to press for approval.
Critics had charged the FDA with gender bias for failing to approve any drugs to improve women’s sex drive, a charge that divided women’s and health organizations.
An “Even the Score” petition urging the FDA to approve a drug for women with low libido collected more than 60,000 signatures. Some members of Congress also got involved, urging the agency earlier this year to approve the medication.
But not everyone jumped on the bandwagon.
“I’m a pro-sex feminist, but I believe that advocating for women’s health means finding solutions for women’s sexual problems that are safe and effective,” Cindy Pearson, executive director of the National Women’s Health Network, wrote June 8 in a Washington Post op-ed piece. “That hasn’t happened. Not yet.”
Pearson’s piece ran 4 days after an FDA advisory panel voted 18-6 in favor of recommending approval of Addyi.
In a statement Tuesday, the FDA noted "a potentially serious interaction" when combining Addyi with alcohol, and said women who drink alcohol should not take it. The drug can cause low blood pressure and fainting, the agency says, and those risks rise when Addyi is combined with alcohol or certain medicines. The drug will be available only through doctors and pharmacies who get training on the risks, the agency says, and it will carry a so-called "boxed warning."
That training includes a slideshow with an assessment afterward, Sprout CEO Cindy Whitehead told reporters Wednesday.