Dare Bioscience to present additional data from Phase 2b RESPOND study

Dare Bioscience announced that additional data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in women with female sexual arousal disorder will be presented at the upcoming International Society for the Study of Women’s Sexual Health Annual Meeting. These data include efficacy results across multiple endpoints in the proposed Phase 3 study population. “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 Dare 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. Sildenafil, a phosphodiesterase-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 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 be the first product approved by the U.S. Food and Drug Administration to treat FSAD. Dare Bioscience previously announced a positive end-of-Phase 2 meeting with the FDA supporting advancement of Sildenafil Cream for the treatment of FSAD. The FDA recently confirmed that it aims to complete its review of the Phase 2b RESPOND study data and provide comments within the second quarter of 2024 on the proposed primary and secondary patient reported outcome endpoints for the planned Phase 3 pivotal trials of Sildenafil Cream to support potential product registration and labeling.