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Daré Bioscience Announces Alignment With FDA On Phase 2b Study Design And Novel Primary Endpoint PRO Instruments To Support Continued Development Of Sildenafil Cream, 3.6% For Female Sexual Arousal Disorder

Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the

Benzinga · 12/11/2019 13:06

Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the outcome of a Type C meeting with the U.S. Food and Drug Administration (FDA) where alignment was reached on the patient reported outcome (PRO) instruments to be used in a Phase 2b clinical study of Sildenafil Cream, 3.6% (Sildenafil Cream) to screen eligible patients with Female Sexual Arousal Disorder (FSAD) and to assess the efficacy of Sildenafil Cream in treating FSAD. The discussions with the FDA followed the completion of a content validity study of the proposed PRO instruments, a non-interventional study integral to initiating the at-home, product dosing portion of the Sildenafil Cream Phase 2b program.