Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 76

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 76
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 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 the Phase 2b study. 

In April 2023, we initiated subject enrollment in a Phase 1, single-dose, double-blind, placebo-controlled, 3-way crossover clinical study of Sildenafil Cream using thermography to assess the PD and pharmacokinetic (PK) characterization of Sildenafil Cream. The study was closed in March 2024. Sildenafil Cream was well tolerated in the study.  Among the 13 enrolled participants, two subjects had a mild vaginal burning sensation following application of Sildenafil Cream and placebo cream. One subject had a mild vaginal burning sensation following application of Sildenafil Cream and placebo cream, which resolved itself and did not require any additional intervention or study withdrawal. Three subjects withdrew from the study for asymptomatic orthostatic tachycardia that occurred during the multiple serial blood draws for pharmacokinetics and one subject withdrew due to bacterial vaginosis. Among the 13 enrolled subjects, ten had adequate paired plasma samples from all three treatments to evaluate. Plasma PK of sildenafil following a single topical (applied externally to the pre-specified vulvar area and internally intravaginally) administration of Sildenafil Cream was characterized and findings were similar to those reported in a prior Phase 1 PK study conducted by our licensor SST.

In June 2023, we announced topline results from our exploratory Phase 2b RESPOND clinical study of Sildenafil Cream in premenopausal women with FSAD, and in July and November 2023, we announced additional findings based on further analyses of data from the study. In 2024, several peer-reviewed journal articles were published on the study, including efficacy findings in Obstetrics & Gynecology, the official journal of the American College of Obstetricians and Gynecologists (ACOG), and safety findings in The Journal of Sexual Medicine, the official journal of the International Society for the Study of Women’s Sexual Health (ISS