Daré Bioscience Announces Publication in The Journal of The North American Menopause Society of Positive Efficacy Findings for the Treatment of Menopausal Symptoms from a Phase 1/2 Clinical Trial of DARE-HRT1 Intravaginal Rings
- DARE-HRT1 Demonstrated Preliminary Treatment Efficacy for Both Vasomotor Symptoms (VMS) and Genitourinary Syndrome of Menopause (GSM)
The North American Menopause Society(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 Administration May offer Advantages Over Orally Administered Therapies
- Daré Plans to Advance DARE-HRT1 into Single Phase 3 Efficacy Trial for Treatment of 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
The journal article, titled “A phase 1/2, open-label, parallel group study to evaluate the preliminary efficacy and usability of DARE-HRT1 (80 μg estradiol/4 mg progesterone and 160 μg estradiol/8 mg progesterone intravaginal rings) over 12 weeks in healthy postmenopausal women,” is available online through both the Latest Articles section of the Menopause journal’s website, as well as the Scientific & Clinical Publications section of Daré’s website, and will be published in Volume 30, Issue 9 of Menopause. The article reports the results of the exploratory objectives of the Phase 1/2 study, which included assessing the usability, acceptability and preliminary efficacy of two dose configurations of DARE-HRT1. The results of the primary objectives of the study, which were to evaluate the safety and pharmacokinetics (PK) of the two dose configurations of DARE-HRT1, are described in a separate article published in an earlier issue of Menopause..
“More women are looking for options to manage their moderate-to-severe vasomotor symptoms that are commonly associated with menopause. We are encouraged by the findings from this study as we believe DARE-HRT1 has the ability to address a persistent unmet medical need,” said
“Data from this study support further development of DARE-HRT1 as a potential first-in-category product to offer bio-identical estradiol and bio-identical progesterone therapy in a convenient monthly, non-oral format, consistent with NAMS guidance for delivering both hormones, together,” said
Hormone therapy is recommended as a first-line, effective treatment for the management of VMS and GSM among healthy postmenopausal women by the
Menopause is defined as the final menstrual period and is typically confirmed after a woman has missed her period for 12 consecutive months. Most women experience menopause between ages 40 and 58.1 Over 45 million women in the
- Menopause 101: A primer for the perimenopausal. NAMS, accessed
27 July 2023. http://www.menopause.org/for-women/menopauseflashes/menopause-symptoms-and-treatments/menopause-101-a-primer-for-the-perimenopausal.
- NAMS Position Statement. The 2022 hormone therapy position statement of
The North American Menopause Society. Menopause: The Journal of The North American Menopause SocietyVol. 29, No. 7, pp. 767-794 DOI: 10.1097/GME.0000000000002028. https://www.menopause.org/docs/default-source/professional/nams-2022-hormone-therapy-position-statement.pdf
DARE-HRT1 505(b)(2) Regulatory Pathway
Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and progesterone, to utilize the U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S.
Daré intends to seek FDA approval of DARE-HRT1 for the treatment of moderate-to-severe VMS due to menopause in women with intact uteri. Based on pre-IND communications with the FDA and the topline PK data from the DARE-HRT1 Phase 1/2 study, Daré believes FDA approval of DARE-HRT1 for that indication is achievable via the 505(b)(2) pathway supported by a single, placebo-controlled, Phase 3 clinical trial of DARE-HRT1 and a scientifically justified PK “bridge” (via a relative bioavailability trial) between DARE-HRT1 and the selected listed estradiol and progesterone drugs. Ongoing activities to support progressing directly into a single Phase 3 study to support registration include manufacturing and non-clinical studies to support the Investigational New Drug Application (IND) submission and the planned IND-opening Phase 3 study.
About Daré Bioscience
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, vaginal health, reproductive health, menopause, sexual health and fertility.
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. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose
Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com),
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to DARE-HRT1’s potential as a safe and effective hormone therapy for symptoms of menopause, DARE-HRT1’s potential to be the first FDA-approved monthly IVR product delivering both estrogen and progestogen hormone therapy for symptoms of menopause, the importance of the results of the Phase 1/2 clinical study to Daré and DARE-HRT1, the anticipated regulatory approval pathway for DARE-HRT1, the potential for FDA approval of DARE-HRT1 for the treatment of moderate-to-severe VMS due to menopause in women with intact uteri based on a single Phase 3 clinical trial together with study data that establishes a scientific bridge to the selected listed drugs, and the potential market opportunity for DARE-HRT1. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, and public health emergencies on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives, including their potential impact on Daré’s ability to timely commence, enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business to fulfill their contractual obligations to Daré; the impact of pharmaceutical industry regulation and health care legislation in
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Source: Daré Bioscience, Inc.