Daré Bioscience Highlights Efficacy Data From Treatment Candidate For Painful Menstruation

Daré Bioscience Inc DARE announced topline results from the Phase 1 DARE-PDM1-001 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1 an investigational product designed to deliver diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), vaginally via its proprietary hydrogel for primary dysmenorrhea.

Dysmenorrhea is defined as painful menstruation in women with normal pelvic anatomy. 

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. 

All adverse events were mild or moderate.

The vaginal fluid PK results exhibited dose proportionality for the 1% and 3% diclofenac strengths of the DARE-PDM1 study treatment. 

Additionally, the vaginal fluid PK results demonstrated that the product was retained in the vaginal canal through 24 hours, which is similar to the vaginal retention demonstrated in the PK study of Daré's FDA-approved vaginal gel product, which uses the same proprietary hydrogel technology.

The exploratory endpoint that evaluated the efficacy of DARE-PDM1 versus placebo in reducing dysmenorrhea-associated pain showed a statistically significant decrease in pelvic/vaginal and lower back pain scores in the 1% diclofenac DARE-PDM1 treatment group compared to the placebo group, as well as a decrease in pain scores in the 3% diclofenac DARE-PDM1 treatment group. 

After the development program, if successful, Daré intends to leverage the existing safety and efficacy data for diclofenac to utilize the FDA's 505(b)(2) pathway to obtain marketing approval for DARE-PDM1 in the U.S.

Price Action: DARE shares are down 3.83% at $0.33 on the last check Wednesday.