The FDA expanded the approval of flibanserin (Addyi), a drug that treats low sexual desire in women, to now include some postmenopausal women, drugmaker Sprout Pharmaceuticals announced on Monday.
Flibanserin is a mixed 5-HT1A agonist/5-HT2A antagonist taken once daily that was approved for premenopausal women with hypoactive sexual desire disorder (HSDD) in 2015. The expanded approval now includes postmenopausal women who are under age 65.
FDA granted the drug a priority review designation earlier this year. Expanded approval was based on data from the SNOWDROP trial, which was published in 2014 and also yielded a post-hoc analysis in 2017.
According to the updated label, the 24-week randomized, double-blind, placebo-controlled trial in postmenopausal women under age 65 showed significant improvement in two co-primary endpoints for the drug compared with placebo: monthly satisfying sexual encounters (an increase of 0.9 vs 0.6, P<0.025) and the desire domain of the Female Sexual Function Index (mean increase of 0.7 vs 0.4, P<0.0001).
Flibanserin was controversial when it was approved in 2015, having been rejected by the agency twice before it was finally approved. A key concern was an interaction with alcohol that left it with a Risk Evaluation and Mitigation Strategy program at the time.
Over time, however, the agency loosened the alcohol warning to indicate that women should stop drinking at least 2 hours before taking the drug. The drug’s boxed warning still notes that taking alcohol and the drug together close in time increases the risk of hypotension and syncope.
In its press release, drugmaker Sprout Pharmaceuticals noted that Health Canada approved flibanserin for expanded use in postmenopausal women in 2021.
In that release, ob/gyn Mary Claire Haver, MD, said flibanserin’s extended approval in the U.S. is “a long-overdue recognition that postmenopausal women deserve evidence-based treatment options for low sexual desire.”
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