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Daré Bioscience Announces Alignment with the FDA on Phase 2b Study Design and Novel Primary Endpoint PRO Instruments to Support the Continued Clinical Development of Sildenafil Cream, 3.6%, a Potential Therapy for Female Sexual Arousal Disorder
Sildenafil Cream, 3.6% has the Potential to Be the First FDA-Approved Product for FSAD SAN DIEGO, Dec. 11, 2019 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc.
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Sildenafil Cream, 3.6% has the Potential to Be the First FDA-Approved Product for FSAD\nSAN DIEGO, Dec. 11, 2019 (GLOBE NEWSWIRE) -- 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.\n “We made excellent progress this year achieving alignment with the FDA on an appropriate and acceptable development plan for a drug to treat FSAD,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Importantly, we aligned with the FDA on the design of our Phase 2b study, including the PRO instruments to be used to measure achievement of the primary efficacy endpoints, namely improvement in localized genital sensations of arousal and reduction in the distress that women with FSAD experience. We are pleased that the FDA recognizes the validity of the PRO instruments to test the efficacy of a drug to treat FSAD that are specific to the Sildenafil Cream mechanism of action. This is a significant milestone in the development of what has the potential to be the first FDA-approved product to treat FSAD. In addition, we aligned with the FDA on several exploratory efficacy endpoints which will be measured in our Phase 2b study and could potentially prove to be additional measurements of efficacy in a future Phase 3 program. We are encouraged by the continued collaborative approach we are experiencing with all FDA divisions and are thrilled to have reached this point in the Sildenafil Cream development program.” Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men and is characterized primarily by an inability to a...