Sildenafil cream demonstrates positive phase 2b results for female sexual arousal disorder

Sildenafil cream, 3.6% has shown positive results in a phase 2b trial in women with female sexual arousal disorder (FSAD), Daré Bioscience has announced.

FSAD, the female sexual dysfunction disorder most synonymous with erectile dysfunction (ED) in men, is defined as, “inability to reach or maintain a sufficient physical response to sexual stimulation.” Unlike hypoactive sexual desire disorder, which presents as a lack of sexual desire, FSAD presents as failure to maintain sufficient genital arousal.

Of men aged 40 years, about 5% experience ED. This increases to about 15% in men aged 70 years. In comparison, data has indicated FSAD impacts 16% of women in the United States aged 21 to 60 years, leading them to seek treatment. Daré Bioscience believes sildenafil may be used as a method of treatment in these women.

Sildenafil is a phosphodiesterase-5 inhibitor taken orally by men with ED. Sildenafil cream is a topical creamof sildenafil made to increase blood flow to the genital tissue in women.

Before sexual activity, Sildenafil cream is applied to the vulvovaginal tissue, leading to vasodilation and increased blood flow to the genital tissue. This increases the physical arousal response, allowing for an overall improved sexual experience for women with FSAD. Data has indicated improvements in blood flow within 15 minutes of dosing.

A multicenter, double-blind, randomized, placebo-controlled study was conducted to determine the safety and efficacy of sildenafil Cream for treating premenopausal FSAD. Women were screened using patient-reported outcome (PRO) instruments, with 2 coprimary endpoints and 1 secondary endpoint measured.

Primary endpoints included sildenafil cream efficacy compared to placebo measured by the Arousal-Sensation Domain of the 28-item Sexual Function Questionnaire (SFQ28) and efficacy measured by the score of feeling concerned from issues with sexual arousal. The secondary endpoint was efficacy measured by responses recorded by an electronic diary.

When measured through the SFQ28, the endpoint of significant change from Sildenafil Cream compared to placebo was not met. However, this endpoint was met when measured through the score of feeling concerned because of difficulties with sexual arousal. 

A higher proportion of satisfying sexual events was also recorded after 4 weeks and after 8 weeks of treatment when measured through an electronic diary within 24 hours after each sexual event. Rates after 4 weeks were 68.6% for sildenafil cream vs 47.9% for placebo, while rates after 8 weeks were 74.1% for sildenafil cream vs 67.9% for placebo.

Exploratory endpoints were also evaluated, including genital arousal, genital blood flow, lubrication, orgasm, concerns about difficulties with sexual arousal, and other measures. When responding about difficulties with sexual arousal, improvements were more often reported in patients taking sildenafil cream compared to placebo.

Greater improvements were also reported in endpoints related to arousal lubrication and orgasm, along with overall satisfaction with sexual activity. According to Sabrina Martucci Johnson, president and CEO of Daré Bioscience, data overall showed therapeutic effects based on several PROs in patients using sildenafil cream.

Daré Bioscience plans to initiate a phase 3 pivotal study to evaluate the effects of sildenafil cream on FSAD. If successful, sildenafil creammay become the first FDA-approved treatment for FSAD in women.

Reference

Daré Bioscience announces positive topline data from the exploratory phase 2b RESPOND study of sildenafil cream, 3.6% in women with female sexual arousal disorder. Daré Bioscience. June 5, 2023. Accessed June 5, 2023. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-positive-topline-data-exploratory