The Food and Drug Administration panel voted 18-6 in favor of approving Sprout Pharmaceutical’s daily pill flibanserin, on the condition that its manufacturer develops a plan to limit safety risks.
Flibanserin was twice rejected since 2010 by the FDA because side effects like sleepiness, dizziness and nausea. The drug treats hypoactive sexual desire disorder, which causes a persistent biological lack of desire for sex that affects 1 in 10 women.
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The positive recommendation is a major victory for the “female Viagra”, but which has been plagued by for years by concerns about its lackluster effectiveness and safety issues.
Testimony from women urged the agency to approve the drug and told about their fears of never being able to have sex again.
Flibanserin does not work in the same way as Viagra, which increases blood flow, as a simple biological function.
Flibanserin, which was first studied as an antidepressant, changes brain chemistry.
