Flibanserin, a drug designed to treat a lack of sexual desire in women, has been recommended for approval by an FDA advisory committee after being rejected twice previously.
The medication, which could be considered a female counterpart to Viagra, has garnered attention from women’s organizations because it represents a step forward for sexual equality.
The New York Times noted the committee’s approval.
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By a vote of 18-6, the advisory committee to the Food and Drug Administration favored approval of the drug, flibanserin, for women whose lack of sexual desire was not attributable to other causes such as disease or relationship troubles, providing that certain steps were taken to limit the risks of the drug. Doctors might be required, for instance, to inform patients of potential side effects — like low blood pressure, fainting, nausea and dizziness — and physicians might have to become certified to prescribe the drug.
A consultant to Sprout Pharmaceuticals, the developer of flibanserin, created a campaign known as “Even the Score” that called out the FDA for gender bias when it comes to options to increase sexual satisfaction.
“The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point,” Tobias Gerhard, a committee member and expert on drug safety at Rutgers University in New Jersey, told the Times.
While many of those involved with the Even the Score coalition believe this is a step forward when it comes to equality, others believe that the mission could end up speeding up the process for approving drugs that might have potentially dangerous consequences.
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“To approve this drug will set the worst kind of precedent — that companies that spend enough money can force the F.D.A. to approve useless or dangerous drugs,” Dr. Adriane Fugh-Berman of Georgetown University told the committee Thursday, according to the Times. She is the director of PharmedOut, a project that questions the influence of drug companies on the practice of medicine.
Advocates for flibanserin feel there is a clear need for a drug to increase female libido. But the reason it has been rejected previously is the potential for side effects, which include low blood pressure and fainting. While these were rare in the clinical trials, it increases the risk of accidental injury — one woman suffered a concussion when she fell.
The deadline for the FDA to make a decision is August 18.
