Daré Bioscience, Inc. 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.

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 blood flow directly to the genital tissue to improve the physical arousal response symptoms commonly associated with FSAD. Increasing blood flow to the genital tissue, as Sildenafil Cream is designed to do, has the potential to improve genital arousal response and overall sexual experience for women. This is similar to the way ED medications work in men by directing blood flow to the genitals when taken prior to sexual activity.

The Phase 2b RESPOND study evaluates Sildenafil Cream compared to a placebo cream in pre- and peri-menopausal women over the course of 12 weeks, in an at-home setting, following both a non-drug and placebo cream run-in period. The Phase 2b RESPOND study is a first of its kind Phase 2b study that includes patient reported outcome (PRO) instruments to screen eligible women with FSAD and a number of primary, secondary, and exploratory PRO assessments to measure improvement in localized genital sensations of arousal and reduction in the distress that women experience with FSAD. There are no FDA-approved treatments for FSAD and thus there are no efficacy endpoints that have been previously validated in Phase 3 pivotal studies for potential treatments for FSAD.

The RESPOND study is designed to test the sensitivity of several efficacy endpoints and their ability to determine a treatment effect of Sildenafil Cream compared to placebo to inform the ongoing development program. Market research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms associated with FSAD, including lack of or low sexual arousal, and are actively seeking solutions to improve their condition. For context on the potential market opportunity for an FDA-approved treatment for FSAD, the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70.