The peer-reviewed article, titled, "A phase 1, open-label, within-participant dose-escalation study to evaluate the safety and pharmacokinetics of topical sildenafil cream in healthy postmenopausal women," reports findings from the clinical study evaluating the systemic and local genital safety and pharmacokinetics of its proprietary Sildenafil Cream in healthy postmenopausal women.

"Women are speaking more openly about the sexual health changes they experience during perimenopause and after menopause, and they are increasingly seeking solutions that address more than vaginal dryness or discomfort," said Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience. "Low genital arousal and diminished sensation can meaningfully affect a woman’s sexual health, relationships and overall quality of life, yet there remains no FDA-approved pharmacological treatment specifically for female sexual arousal disorder. These published results reinforce the potential of DARE to PLAY Sildenafil Cream, designed specifically around female anatomy and the physiology of female sexual arousal."

"Our strategy is designed to provide women with access to the compounded version of our proprietary sildenafil cream formulation now, DARE to PLAY Sildenafil Cream, while we continue activities necessary to seek FDA approval of our proprietary Sildenafil Cream in the future via the 505(b)(2) regulatory pathway," Ms. Johnson continued. "We believe an FDA-approved product could strengthen our competitive position to create a more durable and valuable commercial franchise."

The Phase 1 open-label, within-participant dose-escalation study enrolled 21 healthy postmenopausal women with a mean age of 57. Participants received a single dose of placebo cream followed by escalating doses of Sildenafil Cream containing 50 mg, 100 mg and 200 mg of sildenafil citrate, with a 14- to 16-day washout period between doses. Nineteen participants completed all four treatment periods.

Key findings included:

  • All evaluated doses of Daré’s proprietary Sildenafil Cream were well tolerated.
    • All treatment-emergent adverse events were mild, and there were no serious adverse events.
    • No cardiac treatment-emergent adverse events or episodes of symptomatic orthostatic hypotension were observed.
  • At the 100 mg dose, which was the dose subsequently evaluated in Daré Bioscience’s Phase 2b RESPOND study (ClinicalTrials.gov ID NCT04948151), the maximum plasma concentration of sildenafil was approximately 3,810 pg/mL, which is approximately two orders of magnitude lower than the concentration reported in men following a single 100 mg oral dose (450,000 pg/mL) in a separate clinical study, based on published data.
  • The findings support localized delivery as an approach that may target the genital tissues involved in the female arousal response while limiting systemic exposure.



     

"Women frequently raise concerns about diminished arousal and sensation during and after the menopause transition, yet we have few clinically evaluated options to offer," said Dr. Sheryl Kingsberg, Division Chief of Behavioral Medicine, Department of OBGYN, University Hospitals Cleveland Medical Center, Ohio, and Past President of The Menopause Society and the International Society for the Study of Women's Sexual Health. "These results show that Daré’s proprietary Sildenafil Cream was well tolerated in postmenopausal women with minimal systemic exposure, reinforcing its potential as a localized administration designed specifically to address the genital physiological aspects of female sexual arousal. For our patients, this represents meaningful progress toward addressing a common and often overlooked area of women’s health."

While existing products may help address vaginal dryness or discomfort, there are no FDA-approved products to directly increase genital blood flow in women. When blood flow to genital tissue is reduced, it can make arousal more difficult and decrease natural lubrication and sensation.

The Menopause Society is a leading nonprofit organization dedicated to empowering healthcare professionals and providing tools, resources and education to improve the health of women during the menopause transition and beyond. Its official peer-reviewed journal, Menopause - The Journal of The Menopause Society, is a respected scientific publication featuring original research, applied basic science and clinical guidelines focused on menopause and midlife women’s health. Publication in the journal provides an opportunity to bring greater visibility to an area of women’s health that remains significantly underserved despite increasing awareness and demand for effective solutions. Daré Bioscience is pleased to have its research featured in Menopause and to contribute to the growing body of scientific evidence supporting advances in women’s health and improved care for women throughout the menopause transition and beyond.