A phase 2b study of Sildenafil Cream, 3.6% (Sildenafil Cream; Daré Bioscience) has shown positive results in women with female sexual arousal disorder (FSAD), according to a company press release.
Takeaways
- The phase 2b study of Sildenafil Cream, 3.6%, conducted by Daré Bioscience, has shown positive results in women with female sexual arousal disorder (FSAD), addressing a condition characterized by a continuous inability to achieve genital arousal during sexual activity.
- FSAD is similar to erectile dysfunction (ED) in men, as both conditions are associated with insufficient blood flow to the genitalia. Sildenafil, a phosphodiesterase-5 inhibitor, traditionally used in oral tablets for managing ED, is now being used in Sildenafil Cream to improve female genital arousal response by increasing blood flow when applied to the vulvar-vaginal tissue.
- The phase 2b RESPOND study evaluated the efficacy of Sildenafil Cream in women with FSAD, with some participants having additional sexual dysfunctions. The primary endpoint of the study focused on improvements in arousal dysfunction as the primary complaint, measured over a 12-week double-blind dosing period.
- The study results showed a clinically meaningful improvement in the group using Sildenafil Cream, as measured by the Arousal-Sensation Domain of the Sexual Function Questionnaire, while no such improvement was observed in the placebo group.
- Efficacy was also assessed using the Female Sexual Distress Scale–Desire, Arousal, Orgasm, which demonstrated significant improvements in questions related to inadequacy, embarrassment, and stress due to sexual problems in the Sildenafil Cream group compared to the placebo group.
FSAD is a condition defined by a continuous lack of ability to achieve genital arousal during sexual activity. Patients with FSAD often experience interpersonal difficulty and distress. Additionally, FSAD is most similar to erectile dysfunction (ED) in men, which is associated with insufficient blood flow to the genitalia.
Sildenafil is a phosphodiesterase-5 inhibitor used in an oral tablet designed to manage ED in men. This inhibitor is used in Sildenafil Cream, a proprietary cream which is administered on the vulvar-vaginal tissue and increases genital blood flow, improving female genital arousal response.
The phase 2b RESPOND study was conducted to evaluate the efficacy of Sildenfail Cream. Participants of the study included women with FSAD, with some participants having sexual dysfunctions in addition to FSAD. The primary endpoint of the analysis was improvements in participants with arousal dysfunction as their primary complaint.
Sildenafil Cream was compared to a placebo, with the endpoint measured by change from baseline to the end of a 12-week double-blind dosing period. The Arousal-Sensation Domain of the Sexual Function Questionnaire was used to measure the change. By the end of week 12, a clinically meaningful improvement was reported in the Sildenafil Cream group, while this change was not seen in the placebo group.
Efficacy was also evaluated using the Female Sexual Distress Scale–Desire, Arousal, Orgasm (FSDS-DAO). Significant improvements were seen in FSDS-DAO questions for inadequacy, embarrassment, and stress because of sexual problems in the Sildenafil Cream group compared to the placebo group.
According to Sabrina Martucci Johnson, president and CEO of Daré Bioscience, the company hopes to discuss these results with the FDA later this year. Currently, there is no FDA-approved treatment for FSAD.
Reference
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. Daré Bioscience. November 1, 2023. Accessed November 2, 2023. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-additional-positive-data-phase-2b
