FDA mulls regulatory action on Sprout's 'female Viagra' after adverse events spike
Before there was Biogen’s Aduhelm, there was Sprout Pharmaceuticals’ “female Viagra” pill Addyi. Both FDA-approved drugs stirred up significant controversy because their approvals were based on limited efficacy data and lingering safety concerns.
While Aduhelm is meant to address a significant unmet need in the Alzheimer’s space, Addyi is designed for premenopausal women whose lack of sexual desire causes distress. In the clinical trial supporting its approval, those who took Addyi had an increase of about one sexually satisfying event per month versus those given placebo.
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