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Daré Bioscience Announces Publication in The Journal of Sexual Medicine of Positive Safety Findings from the Phase 2b RESPOND Clinical Study of Sildenafil Cream, 3.6%
Published data show that topical Sildenafil Cream, 3.6% was safe and well tolerated by women and their partners across 1,357 sexual experiences. Use of
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Published data show that topical Sildenafil Cream, 3.6% was safe and well tolerated by women and their partners across 1,357 sexual experiences. Use of topical Sildenafil Cream, 3.6% did not produce the common side effects of headache and flushing associated with oral sildenafil use in women. SAN DIEGO, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that safety and tolerability data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), has been published by The Journal of Sexual Medicine. Publication Details: Thurman, et al. “Safety of topical sildenafil cream, 3.6% in a randomized, placebo-controlled trial for the treatment of female sexual arousal disorder.” The Journal of Sexual Medicine, 2024, 1-7. https://doi.org/10.1093/jsxmed/qdae089 “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.” “Topical sildenafil cream was well tolerated in this study,” said Dr. Annie Thurman, MD, FACOG, lead author of the publication and Medical Director at Daré Bioscience. “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 exploratory Phase 2b RESPOND study evaluated the systemic and local genital safety of Sildenafil Cream, 3.6%, or Sildenafil Cream, among healthy premenopausal women with FSAD and their sexual partners over a 12-week treatment period. Study data demonstrate that Sildenafil Cream was safe and well tolerated among users and their exposed sexual partners. Safety was assessed among participants and their sexual partners after 1,357 and 1,160 sexual experiences in which Sildenafil Cream or placebo cream were used, res...