Daré Bioscience Announces Positive End-of-Phase 2 Meeting with FDA on Development of Sildenafil Cream, 3.6% in Female Sexual Arousal Disorder and Provides Company Focus Areas for 2024 - Seite 2

The EoP2 meeting was supported by positive data from the exploratory Phase 2b RESPOND clinical study, which assessed arousal sensation and evaluated concerns related to difficulties with sexual arousal over a 12-week double-blinded treatment period. The Phase 2b study results identified the subgroup of patients most likely to benefit from therapy and achieve a meaningful improvement, and in those subjects demonstrated that Sildenafil Cream improved arousal sensation, desire, orgasm, as well as stress, guilt, and embarrassment about the sexual dysfunction. The Phase 2b data are being used to enrich the odds of a successful Phase 3 program. There are currently no FDA-approved therapies for the treatment of FSAD.

Building on 2023 Achievements, Looking at 2024

In addition to the significant progress with Sildenafil Cream, Daré continues to build on numerous milestones and achievements from 2023.

“Continued execution against our strategy throughout 2023 has positioned us well for 2024 as we accelerate our portfolio of novel investigational therapies, particularly those that have already demonstrated proof of concept and their potential to expand treatment options, improve outcomes, and enable convenience for women with some of the most persistent unmet needs,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We remain focused on advancing our key pipeline programs, including our ongoing pivotal Phase 3 clinical study for Ovaprene, and continuing efforts toward our goal of advancing Sildenafil Cream into Phase 3 this year. Each of these programs – if approved – represents a potential first-in-category opportunity, and one of the most potentially disruptive therapeutic candidates for women in decades.”

About FSAD and Sildenafil Cream, 3.6%

FSAD, as described in the DSM-IV, is a condition characterized as primarily by a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty, and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. As with ED in men, FSAD is associated with insufficient blood flow to the genitalia.