Daré Bioscience has announced that positive safety and tolerability data from its exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% have been published in The Journal of Sexual Medicine. The study, which focused on an investigational topical cream for female sexual arousal disorder (FSAD), demonstrated that the cream was safe and well tolerated by both women and their sexual partners across 1,357 sexual experiences.
The published data showed that the use of Sildenafil Cream, 3.6% did not lead to common side effects associated with oral sildenafil, such as headaches and flushing, which are often reported by women using oral forms of the medication. This outcome is seen as a promising development in the treatment of FSAD, a condition characterized by the persistent or recurrent inability to achieve or maintain sufficient genital arousal during sexual activity.
“We were very pleased to see a favorable safety and tolerability profile from both patients and their partners in this study,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “This is a particularly robust safety dataset since it includes assessments of both the participants and their partners.”
Dr. Annie Thurman, MD, FACOG, and Medical Director at Daré Bioscience, who is the lead author of the publication, further elaborated on the findings: “Topical sildenafil cream was well tolerated in this study. Because oral sildenafil has known hypotensive effects, we were watching for related side effects such as headache, flushing, nausea, and dizziness. In the RESPOND study with our topical application, however, we did not see these effects, likely due to the hundred-fold lower systemic exposure as compared to oral dosing of sildenafil.”
The Phase 2b RESPOND study evaluated the safety of Sildenafil Cream, 3.6% in both systemic and local genital applications among healthy premenopausal women with FSAD, along with their sexual partners, over a 12-week period. While the study was not designed to demonstrate statistically significant differences in adverse events, the findings provide valuable insights into the safety profile of the cream.
Daré Bioscience is continuing its interactions with the U.S. Food and Drug Administration (FDA) regarding the development of Sildenafil Cream as a treatment for FSAD. The company is also preparing for a planned Phase 3 clinical trial, which will be informed by the exploratory post-hoc analyses from the Phase 2b study.
In addition to the safety findings, efficacy data from the Phase 2b RESPOND study have also been published in Obstetrics & Gynecology, the official journal of the American College of Obstetricians and Gynecologists.
