Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 20

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 20
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 breast disorders”, and events included vaginismus, vulvovaginal burning sensation, vulvovaginal discomfort, and vulvovaginal pain. There were more of these TEAEs under Sildenafil Cream treatment than under placebo (6 and 3, respectively). However, these events were typically transient (lasting less than 1 minute) and resolved without medical attention. A Phase 1, single-dose, double-blind, placebo-controlled, two-way crossover study to evaluate the feasibility of using thermography to assess the pharmacodynamics (PD) of Sildenafil Cream in normal healthy women was conducted at a single center. During the thermography study, genital temperature, a surrogate for genital blood flow, was captured and recorded utilizing an infrared camera capable of detecting heat patterns from blood flow in body tissues. The study, which was designed to evaluate up to 10 subjects, achieved the study objectives based on a planned interim analysis of the first six completed subjects, and thus additional subjects were not enrolled. In this study, Sildenafil Cream demonstrated significantly greater increases in genital temperature compared to placebo cream, indicating a positive impact on genital blood flow during the 30-minute post-dosing testing session, with statistical separation from placebo cream within the first 15 minutes after dosing. Additionally, significantly greater self- reported arousal responses were reported during Sildenafil Cream visits compared to placebo cream visits. One postmenopausal subject had a mild vaginal burning sensation following application of both the placebo cream and Sildenafil Cream, which resolved itself and did not require any additional intervention or study withdrawal. One subject had a small laceration to the perineum post coitus, which was unrelated to study treatment and participation, resolved itself, and did not require additional intervention or withdrawal. In 2019, as part of our exploratory Phase 2b clinical program for Sildenafil Cream, we completed a non- interventional study, or the content validity study, designed to identify and document the genital arousal symptoms that are most important and relevant to women with FSAD. Participants who met the eligibility criteria participated in one- on-one, in-depth interviews conducted by subject matter experts in the field of clinical outcome assessments and female sexual medicine. The findings of that study helped facilitate alignment with the FDA on acceptable efficacy endpoints in our exploratory Phase 2b clinical study and future Phase 3 program, including with respect to the patient reported outcome, or PRO, instruments to be used to screen eligible patients with FSAD and to measure achievement of the primary efficacy endpoint in