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Daré Bioscience Announces Subject Screening for Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder Complete
Approximately 160 to 170 Subjects in Total Are Expected to Complete the Clinical Study;Approximately 100 Subjects Have Completed All Study Assessments to Date
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Approximately 160 to 170 Subjects in Total Are Expected to Complete the Clinical Study;Approximately 100 Subjects Have Completed All Study Assessments to Date 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, Nov. 01, 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 subject screening for the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% is complete, allowing for a topline data announcement target of 2Q-2023. 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). A total of approximately 100 subjects have completed all study assessments to date and, based on the subjects that have completed screening, a total of approximately 160 to 170 subjects are expected to complete the study for inclusion in the topline data assessment targeted for 2Q-2023. 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 look forward to evaluating the topline data next year,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “With no FDA-approved options for women with FSAD, 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.” Unlike the oral formulations of PDE-5 inhibitors, Sildenafil Cream is designed to be applied locally to the vaginal tissue prior to sexual activity to facilitate vasodilation and increased ...