Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 19

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 19
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 Sildenafil Cream is designed to facilitate vasodilation and increase genital blood flow, and, as a result, to provide improvements in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil. Clinical Data In a Phase 1 clinical study conducted by our licensor Strategic Science and Technologies, LLC, or SST, of three escalating doses of topical sildenafil cream (1 g cream with 35 mg sildenafil; 2 g cream with 71 mg sildenafil; and 4 g cream with 142 mg sildenafil) in 20 healthy postmenopausal women using a crossover study design, topical sildenafil cream demonstrated significantly lower systemic exposure to sildenafil compared to a 50 mg oral sildenafil dose, and topical sildenafil cream was well tolerated at clinically relevant doses (1-2 g cream). Study subjects reported favorable product characteristics: easy to use and readily absorbed. In a Phase 2a, single center, single-dose, double-blind, placebo-controlled, 2-way crossover study conducted by SST, women with FSAD, ages 21 to 60, received a single 2 g dose of Sildenafil Cream. Of the 35 women enrolled, 31 (15 premenopausal and 16 postmenopausal) completed the study. The primary objective was to evaluate the efficacy of Sildenafil Cream compared to placebo cream assessed by participant-reported levels of subjective 9

cognitive sexual arousal and by physiological genital arousal response. Sildenafil Cream demonstrated increases in measurable blood flow to the genital tissue compared to placebo (mean change in vaginal pulse amplitude analysis) using a vaginal photoplethysmograph approximately 30 minutes post-dosing. Treatment with a single dose of 2 grams of Sildenafil Cream (71 mg sildenafil) applied intravaginally and externally to the labia minora and clitoris in study participants was well tolerated. No serious adverse events (SAEs) were reported. A total of 18 treatment emergent adverse events (TEAEs) were reported, with a similar incidence under Sildenafil Cream treatment (8 events in 4 participants [12.1%]) and under placebo treatment (10 events in 4 participants [12.1%]). The majority of these TEAEs were considered to be related to treatment (14 out of 18). All TEAEs were all mild or moderate in severity; in particular, TEAEs reported under Sildenafil Cream treatment were all mild. Half of the 18 TEAEs reported were in the system organ classification of “Reproductive system and