Daré Bioscience Announces Additional Positive Data from Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women and Proposed Endpoints and Patient Population for Phase 3 Program
The Phase 2b RESPOND study enrolled women with FSAD and included women who had sexual dysfunctions in addition to FSAD.
- The Phase 2b RESPOND study enrolled women with FSAD and included women who had sexual dysfunctions in addition to FSAD.
- In addition, only the Sildenafil Cream treatment group in this subset, and not the placebo group, demonstrated clinically meaningful improvement at the end of the 12-week period.
- “The further analyses bolster our belief that Sildenafil Cream has the potential to successfully address the significant unmet need of arousal disorder.
- The Phase 3 study design for Sildenafil Cream, including primary and secondary efficacy endpoints and inclusion/exclusion criteria for study participants, will be determined following discussions with the U.S. Food and Drug Administration (FDA), including the company’s end of Phase 2 meeting with the FDA.