Dare Bioscience, Inc. announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1. The Phase 1 study results indicate that the study treatment was well-tolerated, and treatment emergent adverse events profiles were comparable between the DARE-PDM1 treatment groups and the placebo group. Pending the plasma PK data, the topline results of this Phase 1 study support continued clinical development of DARE-PDM 1 for primary dysmenorrhea.

The DARE-PDM1-001 study was conducted in Australia by the company's subsidiary, DARE Bioscience Australia Pty Ltd. At the conclusion of the development program, if successful, Dare 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-PDM2 in the U.S.