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Daré Bioscience Announces Interim Analysis of Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder
Study Enrollment Expected to Complete in 4Q-2022 with Approximately 150 Subjects Topline Data of Phase 2b RESPOND Study Targeted for 2Q-2023 If clinical
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Study Enrollment Expected to Complete in 4Q-2022 with Approximately 150 Subjects Topline Data of Phase 2b RESPOND Study Targeted for 2Q-2023 If clinical development is successful, Sildenafil Cream, 3.6% has the potential to be the first FDA-approved FSAD treatment option SAN DIEGO, Aug. 29, 2022 (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 that, based on the results of an interim analysis to evaluate the relative magnitude of the treatment effect, they expect to complete enrollment in the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in 4Q-2022, allowing for a topline data announcement target of 2Q-2023. The interim analysis was conducted by an independent third-party statistical resource and both Daré and SST continue to remain blinded to results of the study by treatment group. The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD). Sildenafil Cream is a proprietary topical formulation of sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being developed as a first-in-category option for the treatment of FSAD. FSAD is the inability to reach or maintain a sufficient physical response to sexual stimulation and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. Sildenafil is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of ED in men. “We are thrilled to have reached this important milestone for this study this year and look forward to evaluating the topline data next year,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Although numerous pharmaceutical products have been developed, tested and approved by the FDA to treat ED in men, there are no FDA-approved options for women with FSAD, an analogous condition. Completing this Phase 2b study will be a significant milestone in the development of what has the potential to be the first FDA-approved product to treat FSAD. Based on the relative treatment...