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Daré Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6%
Phase 1 Thermography Study Quantitative Data Expected to Complement Patient Reported Outcome Data Collected in the Exploratory Phase 2b RESPOND At-Home Study
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Phase 1 Thermography Study Quantitative Data Expected to Complement Patient Reported Outcome Data Collected in the Exploratory Phase 2b RESPOND At-Home Study Topline Data for the Exploratory Phase 2b RESPOND Study Anticipated in 2Q-2023 SAN DIEGO, April 20, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced initiation of screening and enrollment for a Phase 1 clinical study using thermography to assess the pharmacodynamic and pharmacokinetic characterization of Sildenafil Cream, 3.6% (Sildenafil Cream), a late-stage product candidate being developed as a potential new treatment for female sexual arousal disorder (FSAD). The quantitative pharmacokinetic and pharmacodynamic temperature data captured in a clinic setting in the study are expected to complement the patient reported outcome data collected in the ongoing Phase 2b RESPOND study, where the women use Sildenafil Cream in their home setting. FSAD is the inability to reach or maintain a sufficient physical response to sexual stimulation and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. Sildenafil is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of ED in men. Sildenafil Cream is an investigational proprietary topical cream formulation specifically designed to increase blood flow to the genital tissue in women. If successful, Sildenafil Cream has the potential to be the first FDA-approved treatment for FSAD. “This Phase 1, single-dose, double-blind, placebo-controlled, 3-way crossover study will utilize thermography to assess the pharmacodynamics and pharmacokinetics Sildenafil Cream in comparison with versions of the cream without the active ingredient, sildenafil,” said Andrea Thurman, MD, Medical Director for Daré Bioscience. “The findings from this study, specifically the pharmacodynamic and pharmacokinetic data, are an important part of our comprehensive clinical development and regulatory plan for Sildenafil Cream and will add to our existing clinical and nonclinical data package to support the ongoing development program.” During the thermography ...