After years of consideration, the Food and Drug Administration may finally approve a drug meant to improve female sexual dysfunction.
On Thursday, an advisory committee voted to recommend approval for flibanserin despite some concerns about safety. The panel's main task was to discuss whether the drug's benefits outweighed its risks.
Eighteen members agreed that it did, though only if consumers, physicians and pharmacists are adequately warned of potentially dangerous side effects that include loss of consciousness and low blood pressure, especially when the drug is mixed with alcohol. Six panel members said the drug's risks were considerable, and could not vote for its approval.
Such committees include experts that advise and guide the FDA, but the agency ultimately makes decisions to approve or reject drugs under consideration.
The @US_FDA made #HERstory for women today! #Flibanserin gets stamp of approval from independent FDA panel. More: http://t.co/v0ycFvcN2d— Even The Score (@Eventhescore) June 4, 2015
“With today’s decision, we are one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction," said Cindy Whitehead, chief executive officer of Sprout Pharmaceuticals, flibanserin's manufacturer.
Critics of the process argued that the FDA, in previously refusing to approve the drug, had favored medications for male sexual dysfunction and subjected them to less scrutiny than flibanserin. (In 2010, the panel unanimously voted against approval.)
There is currently no drug available to women who experience loss of sexual desire, and the condition affects 1 in 10 American women.
Female sexuality is complicated, however, women have the right to access medications that impact distressing low desire. #flibanserin— Logan Levkoff, Ph.D. (@LoganLevkoff) June 4, 2015
A campaign called Even the Score, comprising nonprofit advocacy groups and supported by Sprout Pharamceuticals, said the FDA's previous rejection of flibanserin reflected entrenched sexism.
The agency denied these claims in briefing materials for Thursday's meeting: "The FDA’s regulatory decision for each product is based on an assessment of whether the benefits outweigh the risks, and does not take gender into consideration."
The agency has never approved a drug, for men or women, that improves libido. Flibanserin was originally conceived as an antidepressant, and how it increases a woman's sex drive is not currently clear.
The vote in support of approval, however, was heralded by advocates who characterized it as a feminist victory.
Huge moment in #HERstory! 1st treatment for women’s most common sexual complaint gets @US_FDA panel stamp of approval pic.twitter.com/BYyIu4ncAp— NPWH (@NPWH) June 4, 2015
Some of the members who voted yes urged the committee to find effective ways of educating consumers and medical professionals about proper use of the drug, particularly as they encounter an onslaught of advertising.
The FDA is expected to make its final decision on flibanserin later this summer.