Dare Bioscience announces new DARE-PDM1 development program

Dare Bioscience announced a new development program targeted at treating primary dysmenorrhea by delivering the active pharmaceutical ingredient diclofenac, a nonsteroidal anti-inflammatory drug, in a novel way. Dare‘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, Dare intends to leverage the existing safety and efficacy data for diclofenac to utilize the U.S. Food and Drug Administration’s 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 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; and 3) demonstrating clinical success and advancing regulatory and clinical development to enable important 2023 milestones," said Sabrina Martucci Johnson, President and CEO of Dare Bioscience.