Dare announces publication of efficacy results of topical sildenafil cream

Dare Bioscience announced the publication in Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists, of the Phase 2b study efficacy results of topical Sildenafil Cream 3.6%, which is being developed for the treatment of female sexual arousal disordes. The Phase 2b clinical study was designed as an exploratory, multi-center, double-blind, placebo-controlled study to evaluate the preliminary efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with FSAD. Topical Sildenafil Cream improved outcomes among women with FSAD, most significantly in a subset of women both with and without concomitant decreased desire. In an exploratory post-hoc analysis of this group, topical Sildenafil Cream significantly increased sexual arousal sensation and reduced sexual distress, as well as improved desire and orgasm. Dare Bioscience previously announced an end-of-Phase 2 meeting with the U.S. Food and Drug Administration supporting advancement of Sildenafil Cream for the treatment of FSAD and has continued to interact with the FDA as the FDA reviews, specifically, the data generated on the proposed endpoints to take forward into Phase 3 development. The FDA has indicated that it aims to complete its review of the Phase 2b study data and provide comments this quarter on the proposed primary and secondary patient reported outcome endpoints for the planned Phase 3 pivotal trials of Sildenafil Cream to support potential product registration and labeling.