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

Daré Bioscience, Inc. recently 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 $13 billion in 2022 and that the size of this market is expected to increase to $28.5 billion by 2029.

Oral NSAIDs, such as diclofenac, are often recommended for temporary relief from the painful symptoms of primary dysmenorrhea. 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 reproductive age. According to the American College of Obstetricians and Gynecologists’ Committee on Adolescent Health Care, dysmenorrhea is the most common menstrual symptom among adolescent girls and young women, and most adolescents experiencing dysmenorrhea have primary dysmenorrhea. Prevalence rates of dysmenorrhea vary but range from 50% to 90%. A prospective study of college students found that 72% of monitored periods were painful, most commonly during the first day of menses, and 60% of the women studied reported at least one episode of severe pain.

“The most common interventions for primary dysmenorrhea include oral NSAIDs and hormonal contraceptives which often can produce undesirable side effects. Oral NSAIDs, which are available over the counter, may cause an increased risk of gastrointestinal adverse events, including nausea, vomiting, bloating or ulcerations, and hormonal contraceptives can often produce a number of undesirable side effects,” said Dr. Annie Thurman, Medical Director of Daré Bioscience. “Local drug delivery through the vaginal mucosa allows lower doses that specifically target local genital tissues and the myometrium. By leveraging a vaginal route of administration, we believe we can provide a treatment option that addresses the pain-related symptoms of the condition while minimizing side effects commonly seen with use of oral medications.”

The DARE-PDM1 Phase 1 study, DARE-PDM1-001, is a multi-center, randomized, placebo-controlled, double-blind, 3 arm parallel group study of approximately 36 healthy, premenopausal women with primary dysmenorrhea. This study is designed to assess the systemic (plasma) and local mucosal (vaginal fluid) diclofenac pharmacokinetics (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. The study will also assess, 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 will encompass approximately three menstrual cycles.

The DARE-PDM1-001 study will be conducted in Australia by the company’s subsidiary, DARE Bioscience Australia Pty Ltd.

At the conclusion of the development program, if successful, Daré intends to leverage the existing safety and efficacy data for diclofenac to utilize the US FDA 505(b)(2) pathway to obtain marketing approval of DARE-PDM1 in the US.

Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health. Daré’s first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. For more iformation, visit www.darebioscience.com.