Daré Bioscience to Present at the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting - Seite 2

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 Daré 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 be the first product approved by the U.S. Food and Drug Administration (FDA) to treat FSAD.

Daré 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.

About FSAD and Sildenafil Cream, 3.6%

FSAD, as described in the DSM-IV, is a condition characterized primarily by a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty, and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to ED in men. As with ED in men, FSAD is associated with insufficient blood flow to the genitalia.