Daré Bioscience publishes sildenafil cream Phase 1 data in menopause journal

Daré Bioscience, Inc. (NASDAQ: DARE) announced the publication of Phase 1 clinical study results for its topical sildenafil cream, 3.6%, in Menopause - The Journal of The Menopause Society. The study evaluated the safety and pharmacokinetics of the formulation in healthy postmenopausal women.

The 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 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.

All evaluated doses were reported as well tolerated. All treatment-emergent adverse events were mild, with no serious adverse events, no cardiac events, and no episodes of symptomatic orthostatic hypotension observed. At the 100 mg dose, the maximum plasma concentration of sildenafil was approximately 3,810 pg/mL, compared to approximately 450,000 pg/mL reported in men following a single 100 mg oral dose, based on published data.

According to the press release, there are currently no FDA-approved pharmacological treatments specifically for female sexual arousal disorder and no FDA-approved products to directly increase genital blood flow in women.

Daré Bioscience said it is continuing activities to advance its sildenafil cream toward the FDA's 505(b)(2) regulatory pathway, while also launching DARE to PLAY Sildenafil Cream, a 503B compounded version of the formulation. Compounded drug products are not approved by the FDA for safety, effectiveness, or quality. The company said prescription dispensing and initial product revenue from DARE to PLAY Sildenafil Cream are expected to begin in the third quarter of 2026.

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