Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 84

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 84
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 believe there is a clear unmet medical need for an effective non-hormonal treatment for moderate-to-severe dyspareunia, a symptom of GSM .

In December 2023, we announced FDA clearance of our IND application for DARE-VVA1, which was supported by results from our Phase 1/2 clinical study of DARE-VVA1 (discussed below), and we are conducting activities in preparation for a Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1 for moderate-to-severe dyspareunia. At the conclusion of our development program, if successful, we intend to leverage the existing safety and efficacy data for tamoxifen to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of DARE-VVA1 in the U.S. 

13

Clinical Data

An exploratory study of vaginal administration of tamoxifen in four healthy postmenopausal women diagnosed with VVA published in Clinical and Experimental Obstetrics & Gynecology (2019, 46(2), 285-288) demonstrated that tamoxifen self-administered intravaginally for three months clinically benefited women with symptoms of VVA without significant systemic absorption of the study drug. In the open-label prospective cohort study with no placebo arm, participants were instructed to self-administer a vaginal suppository containing tamoxifen (20 mg) daily for one week and twice weekly for three months.  Overall, the study drug was well tolerated. The primary efficacy endpoints evaluated normalization of vaginal pH and improvement of vaginal dryness. Vaginal pH and dryness scores using a visual analog scale were recorded at enrollment and subsequent assessments were recorded using self-assessment questionnaires over a three-month period. Both vaginal pH and vaginal dryness symptoms showed significant improvement after three months compared to baseline, with an approximately 30% improvement in vaginal pH scores and an approximately 63% improvement in vaginal dryness scores. The secondary endpoint was the measurement of tamoxifen concentrations after eight weeks of vaginal tamoxifen administration. When measured after eight weeks on the study treatment, serum tamoxifen levels were negligible, 5.8 ng/ml (median), with a range of 1.0 to 10.0 ng/ml. In comparison, after three months of once daily administration of oral dose of 20-mg tamoxifen, Nolvadex® (tamoxifen citrate) tablets, the average steady state plasma concentration of tamox