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

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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 .

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. 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 treatment. A prior study of DARE-VVA1 published in , demonstrated that weekly vaginal administration of tamoxifen for three months in post-menopausal women with VVA showed improvements in vaginal pH and vaginal dryness without significant systemic absorption of tamoxifen. 

The abstract of the scientific paper entitled “Vaginal tamoxifen for treatment of vulvar and vaginal atrophy: Pharmacokinetics and local tolerance in a rabbit model over 28 days” is available at

Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of 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 expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.

Daré’s product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a hormone-free, monthly contraceptive intravaginal ring; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra®; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone replacement therapy following menopause. To learn more about Daré’s full portfolio of women’s health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

Daré may announce material information about its finances, product candidates, clinical trials and other matters using its investor relations website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré uses these channels to communicate with its investors and the public about the company and other company-related matters. The information Daré posts on its investor relations website may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts on its investor relations website: www.darebioscience.com.

Media on behalf of Daré Bioscience, Inc.:Jake RobisonCanale Communicationsjake@canalecomm.com619.849.5383

Source: Daré Bioscience

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Globe Newswire: 13:00 GMT Wednesday 11th September 2019

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