Last week, Daré Bioscience, in association with Strategic Science & Technologies, LLC (SST), announced that its collaboration with the U.S. Food and Drug Administration (FDA) was reached on the patient-reported outcome (PRO) instruments to be used in clinical trials of Sildenafil Cream for patients with Female Sexual Arousal Disorder (FSAD).
The biopharmaceutical company will assess the safety and efficacy of sildenafil cream in treating FSAD.
President and CEO of Daré Bioscience Sabrina Martucci Johnson said, “We made excellent progress this year achieving alignment with the FDA on an appropriate and acceptable development plan for a drug to treat FSAD.”
“Importantly, we aligned with the FDA on the design of our Phase 2b study, including the PRO instruments to be used to measure achievement of the primary efficacy endpoints, namely an improvement in localized genital sensations of arousal and reduction in the distress that women with FSAD experience,” she added.
Johnson continued, “We are pleased that the FDA recognizes the validity of the PRO instruments to test the efficacy of a drug to treat FSAD that are specific to the Sildenafil Cream mechanism of action. This is a significant milestone in the development of what has the potential to be the first FDA-approved product to treat FSAD.”
“We are encouraged by the continued collaborative approach we are experiencing with all FDA divisions and are thrilled to have reached this point in the Sildenafil Cream development program,” she added.
FSAD is similar to Erectile Dysfunction (ED) in men. In ED, men lose their ability to attain and sustain an erection, while in FSAD, women lose their ability to achieve and sustain sufficient genital arousal. The FDA approved Viagra (sildenafil) tablets for men with ED, but the agency has not yet approved any specific drug for FSAD.
The clinical trials will be conducted on patients with FSAD with sildenafil topical application, which is specifically designed to boost blood flow to the genitals, causing a potential improvement in genital arousal during foreplay.
President and COO of SST Steven Brugger said, “We are very pleased to achieve this alignment with the FDA on the Phase 2b study design. We are excited to be working at the cutting edge of research focused on women’s sexual health and to advance a potential first-in-category treatment option for women suffering with FSAD.”
If found successful, Sildenafil Cream would potentially be the first FDA-approved treatment option for women with FSAD.
Daré Bioscience is a California-based biopharmaceutical company that aims to develop novel therapies for women, improve clinical outcomes, and facilitate convenience. The company focuses on developing new treatments for fertility, sexual and vaginal health, birth control. SST, headquartered in Cambridge, Massachusetts, is a privately funded, clinical-stage biotechnology company with an innovative topical drug delivery technology to formulate known active pharmaceutical ingredients.
