Daré Bioscience Announces Publication of Phase 1/2 Pharmacokinetic, Safety and Pharmacodynamic Data for DARE-VVA1 - a Potential New Hormone-Free Treatment for Vulvovaginal Atrophy - in Climacteric, the Journal of the International Menopause Society

SAN DIEGO, June 09, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced the publication of results of its Phase 1/2 clinical study of DARE-VVA1, a proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvovaginal atrophy (VVA) in women without the use of hormones. The journal article, “Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy,” was published online and will appear in Climacteric, the official journal of the International Menopause Society. The randomized, double-blind, placebo-controlled study was designed to evaluate the pharmacokinetics, safety and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA.

“We are excited to have this peer-reviewed article published in the International Menopause Society’s journal, Climacteric, and share our findings with the broader women’s health community,” said Andrea Thurman, MD, Medical Director for Daré Bioscience and lead author of the journal article. “The data from the study demonstrated safety and tolerability of our investigational product DARE-VVA1, as well as showed an improvement in vaginal cytology parameters and the bothersome vaginal symptoms commonly associated with VVA.”

Daré is developing DARE-VVA1 as a new hormone-free treatment option to address moderate to severe VVA. If successful, DARE-VVA1 has the potential to be an important therapeutic for the treatment of VVA for women currently or previously treated for hormone-receptor positive (HR+) breast cancer and for other women who would like a vaginal, non-hormonal option for VVA treatment.

Globally, breast cancer is the most frequently diagnosed cancer type, accounting for over two million cases each year. Approximately 4 million U.S. women have a history of invasive breast cancer, and of all breast cancer diagnoses in U.S. women, it is estimated that more than 68% are HR+. VVA prevalence in postmenopausal breast cancer survivors is estimated at 42% to 70%.

“The unmet need for an effective non-hormonal treatment for VVA caused by anti-cancer endocrine therapy in patients diagnosed with HR+ breast cancer is undeniable. The current lineup of estrogen-based therapies, commonly used to treat VVA in non-cancer patients, can be challenging for both HR+ breast cancer patients and their providers as the use of estrogen products, in any form, is often contraindicated for the HR+ breast cancer patient population,” said Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience. “If we are successful, vaginally-administered, hormone-free DARE-VVA1 will offer patients and providers an important new treatment option to address one of the most common vaginal side effects associated with breast cancer therapy.”