The first female Viagra will soon be available in the market as a key advisory committee to the Food and Drug Administration has voted 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.
The committee described the drug benefit as “moderate” or “marginal.”
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 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 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.
