Dare Bioscience Inc (DARE) News & EventsDAREDare Bioscience Inc

Dare Bioscience to Present Sildenafil Cream Clinical Data at SMSNA Annual Meeting

Dare Bioscience announced that clinical data from a Phase 1 study that evaluated the company's proprietary Sildenafil Cream, 3.6% investigational product will be presented at the Annual Fall Scientific Meeting of the Sexual Medicine Society of North America, or SMSNA, taking place October 8-11 in Orlando, Florida. The Phase 1 study evaluated the adverse events and relative bioavailability of Dare Bioscience's proprietary topical Sildenafil Cream compared with oral sildenafil in healthy adult men. The study provides additional clinical evidence supporting further clinical development of the company's topical formulation and its potential to deliver sildenafil locally while resulting in substantially lower systemic exposure compared with oral administration. In the study, at the 71 mg topical dose, mean maximum plasma concentration of sildenafil was approximately 187-fold lower compared to the 50 mg oral dose, while systemic exposure measured by area under the curve was approximately 33- to 34-fold lower. All treatment-emergent adverse events reported in the study were mild, with no serious adverse events, severe adverse events, deaths or discontinuations due to treatment-emergent adverse events. Findings from the study were recently published in Sexual Medicine, an official journal of the International Society for Sexual Medicine. The Phase 1 study in men complements Dare Bioscience's clinical development program evaluating Sildenafil Cream in women with female sexual arousal disorder. Dare Bioscience's Sildenafil Cream has been studied in Phase 1, Phase 2a and Phase 2b clinical trials in women. Dare Bioscience is developing Sildenafil Cream as a potential treatment for FSAD, a condition for which there are currently no FDA-approved pharmacological treatments.

Dare Bioscience Publishes Phase 1 Study Results for Sildenafil Cream

Dare Bioscience announced the publication of results from a Phase 1 clinical study evaluating the safety and systemic pharmacokinetics of topical Sildenafil Cream, 3.6% in healthy adult men in Sexual Medicine, an official journal of the International Society for Sexual Medicine. The article discusses findings from the study evaluating a higher and lower dose of topical Sildenafil Cream applied to the penis with and without condom use compared with a 50 mg oral dose of sildenafil. Access the full publication here. The open-label, randomized study enrolled 62 healthy men who received a single dose of either 36 mg or 71 mg of sildenafil in topical cream, with or without condom use, or a 50 mg oral dose of sildenafil in tablet form. The study evaluated safety and systemic pharmacokinetics of sildenafil and its active metabolite, N-desmethyl sildenafil. The study treatments were well tolerated, with all 14 treatment-emergent adverse events reported during the study characterized as mild. Seven of the 14 events occurred in five participants who received oral sildenafil. There were no serious adverse events, severe adverse events, deaths or discontinuations due to treatment-emergent adverse events. Importantly, Dare Bioscience's proprietary topical Sildenafil Cream resulted in substantially lower systemic exposure to sildenafil compared with the oral sildenafil group. Mean maximum plasma concentrations for sildenafil following topical administration ranged from 969 to 1,274 pg/mL, compared with 238,000 pg/mL for the oral sildenafil group. Relative bioavailability of sildenafil following topical administration ranged from 2.55% to 3.20%, suggesting a much lower systemic exposure as compared with the oral sildenafil group. At the 71 mg topical dose, mean maximum plasma concentration of sildenafil was approximately 187-fold lower than following the 50 mg oral dose, while systemic exposure measured by AUClast and AUCinf was approximately 33-fold and 34-fold lower, respectively. 71 mg sildenafil in 2 grams of cream was the dose tested in a subsequent Phase 2b study of Sildenafil Cream, 3.6% in premenopausal women for treatment of female sexual arousal disorder.

Selling Stockholders Plan to Sell Up to 8.93M Shares

This filing relates to the offer and sale from time to time by the selling stockholders of up to 8.93M shares of common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.