Dare Bioscience announces PK, exploratory efficacy results from DARE-PDM1 study

Dare Bioscience announced positive topline results from the Phase 1 study evaluating the pharmacokinetics, PK, safety, and exploratory efficacy of DARE-PDM1. DARE-PDM1 is an investigational product designed to deliver diclofenac, a nonsteroidal anti-inflammatory drug, NSAID, vaginally via the company’s proprietary hydrogel to treat primary dysmenorrhea, which is defined as painful menstruation in women with normal pelvic anatomy. 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. “We are encouraged by these data which indicate that our candidate, DARE-PDM1, was well-tolerated and safe for premenopausal women in both treatment groups,” said Dr. Annie Thurman, Medical Director of Dare Bioscience. “The most common interventions for primary dysmenorrhea include oral NSAIDs and hormonal contraceptives, which often can produce undesirable side effects such as an increased risk of gastrointestinal adverse events, including nausea, vomiting, bloating, or ulcerations. These topline Phase 1 data indicate that by leveraging a vaginal route of administration, we can provide a more convenient and accessible treatment option for women that addresses the pain-related symptoms of the condition while minimizing side effects commonly seen with the use of oral medications.”