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Daré Bioscience Announces Positive Pharmacokinetic (PK) Results from the DARE-HRT1 Phase 1 / 2 Study that Support the Potential of DARE-HRT1 as an Effective Hormone Therapy for both Vasomotor and Vaginal Symptoms of Menopause
Daré Plans to Advance DARE-HRT1 into Single Phase 3 Efficacy Trial for Treatment of Vasomotor Symptoms (VMS) due to Menopause DARE-HRT1 has the potential to
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Daré Plans to Advance DARE-HRT1 into Single Phase 3 Efficacy Trial for Treatment of Vasomotor Symptoms (VMS) due to Menopause DARE-HRT1 has the potential to be the first FDA-approved monthly intravaginal ring delivering both estrogen and progestogen hormone therapy SAN DIEGO, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced topline PK results from its Phase 1 / 2 clinical trial of DARE-HRT1 that support the potential of DARE-HRT1 as an effective hormone therapy (HT) based on the levels of hormones released. DARE-HRT1 is a novel, investigational intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period as part of a HT regimen. HT is used to treat the vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause. DARE-HRT1 has the potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format. Daré plans to advance DARE-HRT1 into a single Phase 3 clinical trial to support a new drug application for DARE-HRT1 for the treatment of moderate to severe VMS due to menopause in women with intact uteri. “The delivery of hormone therapy over a 12-week study via a 28-day intravaginal ring which requires no daily intervention supports DARE-HRT1’s potential to be a first-in-category option, offering ease-of-use and consistent dosing to women suffering from menopausal symptoms. There are currently no FDA-approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks,” said Dr. Annie Thurman, Medical Director of Daré Bioscience. “We believe these Phase 1 / 2 topline data support progressing directly into a single Phase 3 study following the Investigational New Drug (IND) submission to and clearance from the FDA.” Previously reported topline efficacy data from the Phase 1 / 2 study demonstrated improvement in both VMS as well as vaginal symptoms of menopause. The North American Menopause Society’s (NAMS) guidance on hormone therapy states that dosing estrogen and progestogen in combination may offer important benefits to women, and NAMS observed that non-oral routes of administ...