On June 4, an advisory panel to the U.S. Food and Drug Administration (FDA) voted 18-6 in favor of recommending the approval of flibanserin for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women in the United States.
HSDD is a chronic lack of sexual desire that cannot be explained by another medical condition or a substance. Thought to affect one in ten women, HSDD is also marked by emotional distress and can lead to relationship problems.
Currently, there is no FDA-approved treatment for HSDD.
Developed by Sprout Pharmaceuticals, flibanserin works by balancing chemicals in the brain that contribute to sexual response.
The drug has twice been rejected by the FDA because of concerns over effectiveness and safety.
The most recent rejection occurred in 2013. According to an FDA briefing document, the drug did not perform much better than placebo in clinical trials and this benefit did not outweigh the risks. The agency was also concerned about how flibanserin might interact with alcohol and the possibilities of accidental injury during episodes of “central nervous system depression” such as dizziness.
Such concerns were again discussed as last week’s meeting. As a result, the panel recommended implementation of risk management strategies prior to prescribing, such as warning labels and explanations of side effects like fainting, low blood pressure, and sleepiness.
The panel also proposed that physicians be certified to prescribe flibanserin and that pharmacies confirm such certifications.
Proponents of the drug saw the recommendation as a victory for women’s sexual health.
“We applaud the FDA’s recognition of female sexual dysfunction as a key unmet medical need. We urge the FDA to make in history in August by issuing final approval of the first-ever medical treatment option for women’s most common sexual complaint,” said Susan Scanlan, chair of Even the Score, an organization that advocates treatment for female sexual dysfunction.
The panel’s recommendation has its critics, too.
“I’m a pro-feminist, but I believe that advocating for women’s health means finding solutions for women’s sexual problems that are safe and effective. That hasn’t happened. Not yet,” wrote Cindy Pearson, executive director of the National Women’s Health Network in The Washington Post on June 8th.
Pearson added that flibanserin has “either failed or barely passed” clinical trials of effectiveness.
The panel’s decision does not mean flibanserin has been approved by the FDA. While the agency usually follows the advisory committee recommendations, it is not bound to them.
The agency’s decision deadline is August 18, The New York Times reports. If approved, the drug will be marketed under the brand name Addyi.
“Even The Score Applauds FDA Advisory Committee as it Makes #Herstory by Recommending Approval of First-Ever Medical Treatment for Women’s Most Common Sexual Dysfunction”
(Press release. June 4, 2015)
“FDA Panel Endorses Women's Libido Pill”
(Updated: June 5, 2015)
New York Times
“‘Viagra for Women’ Is Backed by an F.D.A. Panel”
(June 4, 2015)
“FDA Advisory Committee Recommends Approval for Sprout Pharmaceuticals’ ADDYI™ (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women”
(News release. June 5, 2015)
U.S. Food and Drug Administration
“FDA Briefing Document”
(June 4, 2015)
“I’m a feminist. Here’s why I don’t support the ‘female Viagra.’”
(June 8, 2015)