Dare Bioscience reports positive Phase 1 topline results for DARE-PDM1 in primary dysmenorrhea

Dare Bioscience, Inc.

DARE-PDM1 (vaginal diclofenac hydrogel) was well-tolerated; no serious AEs; 85% of AEs mild.
Vaginal fluid PK showed dose proportionality and retention in vaginal canal for 24 hours.
Exploratory efficacy: statistically significant reduction in pelvic/vaginal and lower back pain for 1% DARE-PDM1 vs placebo.
Plasma PK data pending; company plans continued development and 505(b)(2) regulatory pathway.
DARE-PDM1 has potential as first-in-category vaginal treatment for primary dysmenorrhea; market estimated $13B in 2022.

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