DARE-PDM1 has demonstrated topline safety, efficacy, and pharmacokinetic (PK) results in a phase 1 clinical trial, according to Daré Bioscience.
Takeaways
- The phase 1 clinical trial of DARE-PDM1, a potential treatment for primary dysmenorrhea, demonstrated positive topline results in terms of safety, efficacy, and pharmacokinetics (PK).
- Primary dysmenorrhea, the condition DARE-PDM1 aims to treat, was estimated to have a market value of $13 billion in 2022. This value is projected to increase to $28.5 billion by 2029.
- DARE-PDM1 stands out as a potential first-in-category product because it utilizes a proprietary hydrogel to deliver diclofenac vaginally, offering an alternative route of administration compared to existing oral treatments.
- The clinical assessment involved 42 premenopausal women across multiple centers. Results showed that DARE-PDM1 was well-tolerated, with mild or moderate adverse events. Additionally, the product demonstrated effective pain relief, as evidenced by statistically significant reductions in pelvic and lower back pain scores compared to the placebo.
- The positive outcomes from the phase 1 trial support the continued clinical development of DARE-PDM1 for the treatment of primary dysmenorrhea.
DARE-PDM1 is an investigational product being developed to treat primary dysmenorrhea, which presents as painful menstruation in female patients with normal pelvic anatomy. In 2022, research indicated primary dysmenorrhea had an estimated market value of $13 billion, with an estimate rise of this value to $28.5 billion expected by 2029.
Oral nonsteroidal, anti-inflammatory drugs such as oral diclofenac often provide temporary relief from symptoms associated with primary dysmenorrhea. However, there are currently no FDA-approved products that deliver diclofenac treatment vaginally.DARE-PDM1 uses a proprietary hydrogel to deliver dysmenorrhea, making it a potential first-in-category product.
The clinical outcomes of DARE-PDM1 were assessed in a multi-center, randomized, placebo-controlled, double-blind, 3-arm parallel group study. Participants included 42 premenopausal women presenting with symptomatic primary dysmenorrhea.
DARE-PDM1 was assessed as a single dose and as 3 doses per day, with both 1% and 3% diclofenac in 2.5 mL of hydrogel evaluated. Systemic and local mucosal diclofenac PK and safety were compared with placebo.
The efficacy of DARE-PDM1 for treating dysmenorrhea when administered in 3 doses per day from symptom onset was measured as the primary outcome of the analysis. This outcome was evaluated throughout 3 menstrual cycles.
Results indicatedDARE-PDM1 was well-tolerated, with all adverse events being mild or moderate and 85% of adverse events being mild. No severe adverse events or cases of treatment discontinuation because of adverse events were reported.
PK results showed retention of the product in the vaginal canal through 24 hours. This is similar to the vaginal retention in Daré’s FDA-approved vaginal gel product using the same proprietary hydrogel technology as DARE-PDM1.
A statistically significant decrease in pelvic and lower back pain scores was observed in patients receiving 1% diclofenac DARE-PDM1 treatment vs placebo. Pain scores were also significantly decreased in patients receiving 3% diclofenac DARE-PDM1 treatment vs placebo.
The use of a non-pharmacologic pain relief method for treating dysmenorrhea-related pain was reported in most participants before treatment, but this rate decreased significantly in the DARE-PDM1 treatment groups during the dosing period. Overall, these results supported continued clinical development of DARE-PDM1 for primary dysmenorrhea.
Reference
Daré Bioscience announces positive topline pharmacokinetic and exploratory efficacy results from the DARE-PDM1 phase 1 clinical study. Daré Bioscience. December 20, 2023. Accessed December 21, 2023. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-positive-topline-pharmacokinetic-and
