Daré Bioscience, Inc. Announces Positive Results in Thermography Feasibility Study with Sildenafil Cream, 3.6%, a Potential Therapy for Female Sexual Arousal Disorder
Sildenafil is the active ingredient in a tablet for oral administration marketed under the brand name Viagra®, which is indicated for the treatment of erectile dysfunction (ED) in men. Daré Bioscience, in collaboration with
“The results from the first six subjects to complete all assessments indicate the utility of thermography technology to detect statistically meaningful differences in genital temperature changes, a surrogate for genital blood flow, and support the ongoing evaluation of Sildenafil Cream as a treatment for FSAD,” said Dr.
The principal investigator for the thermography study, Dr.
“This study is part of our larger FSAD development program for Sildenafil Cream, and these findings give us greater insight into the physiologic activity and time-to-effect that we should expect to see in the larger studies currently planned for the program,” said
During the thermography study, genital temperature, a surrogate for genital blood flow, was captured and recorded utilizing an infrared camera capable of detecting heat patterns from blood flow in body tissues. The study, which was designed to evaluate up to 10 subjects, achieved the study objectives based on a planned interim analysis of the first 6 completed subjects, and thus additional subjects will not be enrolled. The assessments consisted of the screening visit (visit 1), the double-blind dosing of placebo or active Sildenafil Cream (visits 2-3) and a safety follow-up. The thermography study is part of a comprehensive clinical development and regulatory plan for Sildenafil Cream that Daré Bioscience intends to implement in collaboration with SST. The development plan includes an ongoing non-interventional study intended to support the validity of FSAD-specific patient reported outcome (PRO) measures to be utilized to assess efficacy of Sildenafil Cream in Phase 2 and Phase 3 clinical studies, as well as an at-home dosing study anticipated to commence before the end of 2019, which together constitute the Sildenafil Cream Phase 2b program.
Market research suggests that 33% of women in the U.S., ages 21 to 60 years old, experience symptoms of low or no sexual arousal, and 16%, or approximately 10 million women, are distressed and are seeking a solution to improve their condition. To put the market opportunity for an
About Daré Bioscience
Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.
Daré’s product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a non-hormonal, monthly contraceptive intravaginal ring; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra®; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone replacement therapy following menopause. To learn more about Daré’s full portfolio of women’s health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
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