Our Pipeline:
DARE-PDM1
POTENTIAL FIRST-IN-CATEGORY PRODUCT, DELIVERING DICLOFENAC IN A CONVENIENT VAGINAL FORMAT
About Primary Dysmenorrhea
Primary dysmenorrhea is defined as painful menstruation in women with normal pelvic anatomy, typically described as cramping pain in the lower abdomen before or during the menstrual period. Recent market research suggests that the global market for dysmenorrhea treatment was estimated to be valued at USD $13 billion in 2022 and that the size of this market is expected to increase to USD $28.5 billion by 2029. The most common interventions for primary dysmenorrhea include oral NSAIDs and hormonal contraceptives which often can produce undesirable side effects.
Our Investigational Candidate, DARE-PDM1
DARE-PDM1 has the potential to be a first-in-category product, delivering diclofenac in a convenient vaginal format that may extend the duration of pain relief and reduce the risks associated with the oral delivery of NSAIDs. There are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea.
Phase 1 Clinical Study, completed 2023
Phase 1 Study Design
The DARE-PDM1 Phase 1 study, DARE-PDM1-001, was a multi-center, randomized, placebo-controlled, double-blind, 3-arm parallel group study among approximately 42 healthy, premenopausal women with symptomatic primary dysmenorrhea. This study was designed to assess the systemic (plasma) and local mucosal (vaginal fluid) diclofenac PK and safety after a single dose and during three daily doses of vaginally administered DARE-PDM1, given in two different strengths (1% or 3% diclofenac in 2.5 mL of hydrogel) versus placebo (vaginal hydrogel, no active ingredient). The study also assessed, as an exploratory endpoint, the preliminary dysmenorrhea treatment efficacy of DARE-PDM1, when dosed in three daily doses at the onset of dysmenorrhea symptoms, compared to a no-treatment, baseline, control cycle. The study observation period encompassed approximately three menstrual cycles.
Topline Results of the Phase 1 Study
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; most adverse events (85%) were mild. There were no early discontinuations due to an adverse event, and no serious adverse events were reported.
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 promising signal, with 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. Additionally, while most participants used at least one non-pharmacologic pain relief method (e.g., heating pad) for dysmenorrhea-associated pain during the no-treatment, baseline, control cycle, the proportion of participants who used at least one non-pharmacologic pain relief method for dysmenorrhea-associated pain decreased significantly in the DARE-PDM1 treatment groups during the dosing period, but not in the placebo group. There was no difference in the exploratory assessment of frequency of use of rescue medications in the treatment phase between the three groups.
Pending the plasma PK data, the topline results of this Phase 1 study support continued clinical development of DARE-PDM1 for primary dysmenorrhea.
The DARE-PDM1-001 study was conducted in Australia by the company’s subsidiary, DARE Bioscience Australia Pty Ltd.
Read more about the Phase 2b clinical study here (please link to the Press Release)
At the conclusion of the development program, if successful, 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.