Daré Bioscience Announces Start of a Phase 1 Study for its Potential First-in-Category Treatment for Primary Dysmenorrhea, DARE-PDM1

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[{"type":"text","content":"SAN DIEGO, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the start of a Phase 1 study evaluating its development program targeted at treating primary dysmenorrhea by delivering the active pharmaceutical ingredient diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), in a novel way. Daré’s investigational product, DARE-PDM1, will deliver diclofenac vaginally via the Company’s proprietary hydrogel. 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 2029¹. Oral NSAIDs, such as diclofenac, are often recommended for temporary relief from the painful symptoms of primary dysmenorrhea². Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, 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. “The potential benefits of DARE-PDM1 as a potential treatment for the millions of women suffering from primary dysmenorrhea are driven by its unique target product profile,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Its key attributes include the utilization of a well-known and well-characterized active pharmaceutical ingredient for the condition, delivery of the active utilizing our novel hydrogel delivery technology which is designed to keep the product from leaking out of the vagina and may increase the vaginal residence time and, most importantly, the opportunity for local vaginal administration to reduce the frequency and severity of systemic side effects associated with commonly recommended and prescribed oral medications, such as oral NSAIDs and oral hormone contraceptive products.” Primary dysmenorrhea usually begins during adolescence and is a leading cause of recurrent short-term school absence in adolescent girls and a common problem in women of reproduct...

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