The first-ever “female Viagra” came one step closer to coming to market, as a key advisory committee to the Food and Drug Administration voted Thursday afternoon to recommend that the FDA approve the drug with conditions.
The committee voted 18-6 to recommend that the FDA approve flibanserin, a drug designed to boost the low sexual desire of otherwise healthy women.
The FDA usually follows the recommendations of its advisory committees, but not always. Its decision is expected by the end of the summer. The agency has already rejected the drug twice, saying the potential side effects of fainting, nausea, dizziness, sleepiness and low-blood pressure outweighed its benefits. Even on Thursday, the committee described the drug benefit as “moderate” or “marginal.”
The benefits of the drug are marginal, panelists said, but meaningful for some patients. Serious side effects include the risk of fainting at unpredictable times, accidental injury and low blood pressure.
But after an afternoon of emotional testimony from women who suffer from low sexual desire, a condition called Hypoactive Sexual Desire Disorder, the majority of committee members said that, with proper warning labels and education, the drug, even with a moderate benefit, should be made available to women who now have nothing.
One practitioner said that when her patients asked her for help,”This is all I can tell them.” And then she stood in front of the microphone in silence for several uncomfortable minutes.
Some of the women speaking Thursday described the condition as if a switch had gone off, they don’t understand why they no longer want to have sex, and find it distressing.
Before a packed hearing room, Sprout Pharmaceuticals, developers of the drug, presented the results of a series of double-blind clinical trials that showed the drug worked better than placebo to boost women’s sexual desire, increased the number of sexually satisfying events and lowered women’s distress at the loss of their libido.
After 24 weeks, they said, 46 to 60 percent of the women in the trials had benefited from the flibanserin treatment. But some committee members said, after adjusting the data to take the placebo effect into account, the drug wound up helping only about 10 percent of the women in the trials.
