DARE Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovations, has just announced the publication of safety and acceptability results in Climacteric, the official journal of the International Menopause Society.
The results are from a Phase 1 clinical trial of DARE-HRT1, a revolutionary intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol (E2) and progesterone (P4) for up to 28 days. DARE-HRT1 is being developed to treat moderate-to-severe vasomotor symptoms (VMS) due to menopause in women with intact uteri.
Hormone therapy is revolutionizing the way we treat the uncomfortable effects of menopause. DARE-HRT1 is leading the charge, offering the first FDA-approved product to deliver the combination of bio-identical estradiol and progesterone in a convenient, monthly form. The North American Menopause Society’s (NAMS) guidance on hormone therapy has noted the key advantages of this non-oral delivery, promising relief and improved quality of life.
Daré Bioscience is thrilled with the results from its Phase 1 trial of DARE-HRT1, a candidate that was found to be highly tolerable and accepted by the majority of women in both its IVR treatment groups. The data was recently published in a recognized peer-reviewed journal, showcasing the scientific rigor of the development process and the innovative IVR drug delivery technology platform.
Thirty postmenopausal women participated in a groundbreaking Phase 1 study of the DARE-HTR1 ring: an innovative Intravaginal Ring (IVR) delivering a controlled release of Estrogen (E2) and Progesterone (P4).
The women were divided into three arms: the first arm received a DARE-HTR1 ring releasing E2 at 80 μg/day and P4 at 4 mg/day, the second arm received an alternative DARE-HTR1 ring releasing E2 at 160 μg/day and P4 at 8 mg/day, and the third arm received oral Estrofem® (1mg E2) and Prometrium® (100 mg P4) daily.
The primary objective of the study was to assess the pharmacokinetics of the two dosage strengths of the DARE-HRT1 IVRs, while the secondary objective was to assess safety. Usability and participant tolerability of the IVRs were also explored.
The study showed that the DARE-HRT1 IVRs were safe and generally well-tolerated in postmenopausal women, with the same treatment-emergent side-effect profiles as those taking the reference oral regimen. These results indicate that DARE-HRT1 is a viable and effective option for managing the health concerns of postmenopausal women.
Daré Bioscience’s innovative drug delivery technology, developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School, is revolutionizing the way women take medication.
The IVR technology used in DARE-HRT1 offers a number of advantages over current medications, including improved compliance, avoidance of first-pass metabolic side effects, and a more pleasant user experience. This groundbreaking platform has the potential to improve health outcomes for women everywhere.
Daré’s Phase 1/2 study of DARE-HRT1 revealed promising results, demonstrating improvements in both vasomotor symptoms and vaginal symptoms associated with menopause. Daré is now leveraging the safety and efficacy data of estradiol and progesterone, the components of DARE-HRT1, to obtain FDA-approval of the product in the U.S. through the 505(b)(2) pathway.
About Menopause
Menopause is a transition period in a woman’s life when the levels of hormones such as estrogen decrease, which can cause a variety of symptoms. Hot flashes, night sweats, and vaginal dryness are the most common symptoms, with 45 million American women estimated to be dealing with them.
The North American Menopause Society (NAMS) recommends hormone therapy as the most effective treatment for these symptoms, as it can help improve quality of life, productivity, and overall health. Non-oral routes of administration may even offer an advantage, allowing women to take control of managing their menopausal symptoms.
About Daré Bioscience
Daré Bioscience is a pioneering biopharmaceutical company dedicated to improving women’s health. We strive to develop innovative treatments that prioritize women’s health, expand treatment options and enhance outcomes, particularly in the fields of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. Our goal is to provide women with the support they need to reach their highest potential.
Daré is a leading women’s health company dedicated to delivering innovative therapies to improve the lives of women. Its 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, and is under a global license agreement with Organon. XACIATO is a clear, colorless, viscous gel, administered intravaginally as a single dose.
Daré is also developing a number of potential first-in-category candidates including Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive licensed 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 menopausal hormone therapy. With a mission to empower women’s health, Daré is revolutionizing the way women manage their health and wellness.