The first drug for lack of sexual desire in premenopausal women may be available soon following a recommendation this week by a federal committee.
An advisory committee to the Food and Drug Administration (FDA) urged the agency to approve flibanserin — dubbed “the female Viagra” by the media — for the treatment of so-called hypoactive sexual desire disorder (HSSD) in women. But that recommendation was conditioned on safety measures being put into place.
Flibanserin could be approved by Aug. 18. The FDA usually approves drugs that have won recommendation by an advisory panel, but a green light is not guaranteed.
HSDD is defined as “the persistent or recurrent deficiency or absence of sexual thoughts, fantasies, and/or desire for sexual activity, which causes marked distress or interpersonal difficulty,” according to an FDA briefing document.
An FDA spokeswoman declined to comment Friday, saying the agency was able to provide information only on approved drug applications.
Cindy Whitehead, chief executive officer of flibanserin maker Sprout Pharmaceuticals, said in a statement, “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.” A spokeswoman reached by email declined to speculate on the outcome of the FDA process.
About one in three American women suffer from low sexual desire, the company said.
The FDA usually approves drugs that have won recommendation by an advisory panel, but a green light is not guaranteed.
Flibanserin is believed to work on key neurotransmitters in the brain that affect sexual desire.
Applauding the advisory committee’s vote was the group Even the Score, which accuses the FDA of unfairly limiting drugs for women’s sexual problems while approving treatments for men.
“The Advisory Committee’s recommendation has historic repercussions. First, for the 1-in-10 women who are living with HSDD without a single approved medical treatment for their condition. And second, it will mean the difference between opening a pipeline of future options for women’s sexual health and closing it for good,” said Susan Scanlan, chairwoman of Even the Score.
The FDA “strongly rejects” claims of gender bias, it said in a statement. “We are committed to working with companies to develop safe and effective treatments for female sexual dysfunction, as we do for all diseases with unmet medical needs.”
Critics have said flibanserin has not been shown to be effective and safe.
A separate process is required in order for the drug to be approved for postmenopausal women.
Researchers conducted a large clinical trial for that demographic that showed similar results, said Sheryl A. Kingsberg, chief of behavioral medicine at University Hospitals Case Medical Center at Case Western Reserve University.
“We have the results of it, and we offered to show (those) yesterday, because somebody asked,” Kingsberg said. “I think the plan will be to get it approved in postmenopausal women.”
A testosterone patch was previously approved for low female libido in several European countries, but has since been withdrawn.
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