Sprout Pharmaceuticals announced that it has resubmitted the New Drug Application (NDA) for flibanserin earlier this year for the a non-hormonal treatment of Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. The resubmission was based on a recent publication of positive results from its Phase 3 clinical trial.
Study 511.147 was a randomized, placebo-controlled trial in which nearly 1,100 pre-menopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100mg once daily at bedtime or placebo for 24 weeks. Co-primary end points were the change from baseline to study end in number of satisfying sexual events and increases in desire as measured by the Female Sexual Function Index (FSFI) desire domain score. Further, clinical meaningfulness of outcomes was assessed using the FDA recommended Patient Global Index of Improvement (PGI-I). All endpoints achieved statistical significance.
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