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Daré Bioscience Announces New Development Program, DARE-PDM1, as a Potential First-in-Category Treatment for Primary Dysmenorrhea
DARE-PDM1 Utilizes Proprietary Hydrogel Technology for Vaginal Delivery of Diclofenac, a Nonsteroidal Anti-Inflammatory; Phase 1 Study Targeted for 2023 2022
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"DARE-PDM1 Utilizes Proprietary Hydrogel Technology for Vaginal Delivery of Diclofenac, a Nonsteroidal Anti-Inflammatory; Phase 1 Study Targeted for 2023 2022 Daré Portfolio Accomplishments Include: Two Additional Portfolio Programs (DARE-GML and grant-funded DARE-LBT); License Agreement with Organon to Commercialize XACIATO™; Ovaprene® IDE Approval for Pivotal Contraceptive Efficacy Study; Positive Phase 1/2 Data for both DARE-HRT1 and DARE-VVA1 2023 Anticipated Milestones Include: XACIATO First Commercial Sale; Sildenafil Cream, 3.6% for Female Sexual Arousal Disorder Phase 2b Topline Data; Ovaprene Pivotal Study Recruitment; DARE-PDM1 Phase 1 Study SAN DIEGO, Dec. 12, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced a new development program targeted at treating primary dysmenorrhea by delivering the active pharmaceutical ingredient diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), in a novel way. Daré’s new investigational product, DARE-PDM1, will deliver diclofenac vaginally via the Company’s proprietary hydrogel technology. A Phase 1 study of DARE-PDM1 is targeted for 2023. Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential to be a first-in-category product. Following clinical development, Daré intends to leverage the existing safety and efficacy data for diclofenac to utilize the U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-PDM1 in the U.S. “Calendar 2022 has been an incredibly successful year for our portfolio in terms of:1) expanding our portfolio with additional differentiated product candidates that we believe further our leadership as an accelerator of innovative products in women’s health; 2) securing a global commercialization collaboration for our first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel, 2%, a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older, which is the second commercial collaboration agreement for our portfolio (the first was entered into with Bayer in 2020 for Ovaprene); and 3) demonstrating clinical success (such as with DARE-HRT1 and DARE-VVA1) and advancing regulatory and clinical development to enable ...