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Daré Bioscience Announces the Publication of a Pharmacokinetics Study of DARE-VVA1, a Novel Application of Tamoxifen for the Treatment of Vulvar and Vaginal Atrophy, in the International Journal of Pharmaceutics
SAN DIEGO, Sept. 11, 2019 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced the article entitled
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"SAN DIEGO, Sept. 11, 2019 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced the article entitled “Vaginal tamoxifen for treatment of vulvar and vaginal atrophy: Pharmacokinetics and local tolerance in a rabbit model over 28 days” was published online in the International Journal of Pharmaceutics.\n The article highlights the positive findings from the animal study which include availability and local tolerability of vaginally delivered tamoxifen. DARE-VVA1 is a novel vaginal application of tamoxifen, the well-known and well-characterized selective estrogen receptor modulator (SERM), and is being developed by Daré as an alternative to estrogen-based therapies for the treatment of vulvar and vaginal atrophy (VVA) in women with or at risk for hormone-receptor positive (HR+) breast cancer. In breast tissue, tamoxifen acts as an estrogen antagonist, while in other tissue, including vaginal tissue, tamoxifen has been reported to exert an estrogen-like response on vaginal cytology. The goal of the study was to evaluate tamoxifen at two dose levels (1 mg or 20 mg) administered intra-vaginally to female rabbits once-daily over a 28-day period to assess its pharmacokinetics, systemic exposure and local vaginal tolerance. The findings revealed that there was little to no vaginal or systemic accumulation of tamoxifen following once-daily dosing for 28 days and that vaginal irritation was minimal to none at both doses. “We are highly encouraged by these findings as tamoxifen was minimally metabolized at both doses with essentially no detectable vaginal irritation evident over the course of the study,” said David Friend, PhD, co-author of the article and Chief Scientific Officer of Daré Bioscience. VVA is an inflammation of the vaginal epithelium due to the reduction in levels of circulating estrogen. Commonly used therapies for VVA are estrogen-based and often contraindicated in HR+ breast cancer patients, or patients with a genetic predisposition or history of familial disease, because of the concern that estrogen use will promote recurrence of disease.1 Many breast cancer survivors experience menopausal symptoms as a direct consequence of cancer treatment. Breast cancer patients treated with aromatase inhibitors refer to VVA as one of the most unpleasant side effects of treatmen...