DARE - Dare? Bioscience to Present at the International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting | Benzinga

Data to be presented demonstrate increased frequency of sexual events with Sildenafil Cream, 3.6% use in the Phase 2b RESPOND clinical study, as well as improvement in multiple aspects of the sexual experience

Continuing to work toward Phase 3 pivotal study

There are no FDA-approved treatments for female sexual arousal disorder

SAN DIEGO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Dare? Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that additional data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% (Sildenafil Cream) in women with female sexual arousal disorder (FSAD) will be presented at the upcoming International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting. These data include efficacy results across multiple endpoints in the proposed Phase 3 study population.

Presentation Details

"The data from the Phase 2b RESPOND study demonstrate that Sildenafil Cream treatment reduced sexual distress across multiple measures in a clinically meaningful way," said Dr. Andrew Goldstein, Medical Advisor for Daré Bioscience and former President of ISSWSH. "The results highlight specific endpoints with the strongest responses including arousal sensation, desire, orgasm, as well as stress, guilt, and embarrassment about the sexual dysfunction. Most importantly, based on these responses, we've identified the study population that will likely demonstrate the most significant benefit from Sildenafil Cream treatment, which consists of healthy premenopausal women with female sexual arousal disorder, including those who suffered from a lack of sexual desire due to their decreased arousal."

Dr. Goldstein will also present data on sexual experiences from the study, which showed that Sildenafil Cream users had more sexual experiences and more solo sexual experiences than placebo users. Notably, Sildenafil Cream enhanced solo, unpartnered sexual experiences, which represented approximately 1 in 5 sexual events in the Phase 2b RESPOND study.

"We are excited to share additional data from this groundbreaking study in one of the leading forums for scientific research on female sexual dysfunction," said Sabrina Martucci Johnson, President and CEO of Dare? Bioscience. "This is an area of significant unmet need and the improvements demonstrated in the Phase 2b RESPOND study in the target population we want to take forward to the Phase 3 program provide an important step towards advancing this potential first-in-category treatment for this challenging condition. We will continue to work with the FDA to align on and finalize the planned Phase 3 program for Sildenafil Cream."

Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of erectile dysfunction (ED) in men. Sildenafil Cream is an investigational, proprietary topical cream formulation specifically designed to be used on-demand at the time of sexual activity to increase blood flow to the genital tissue in women. If development is successful, Sildenafil Cream has the potential to ...

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