Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 29

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 29
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 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 tamoxifen is 122 ng/ml (range of 71 to 183 ng/ml). DARE-VVA1 has also been evaluated in a Phase 1/2 clinical study conducted by our wholly-owned subsidiary in Australia. The randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study enrolled 17 postmenopausal women with moderate-to-severe VVA and evaluated the safety, tolerability, plasma PK and PD of DARE-VVA1. The age of the 17 study participants ranged from 49 to 68 years, with an average age of 60.9 years. Participants were randomly allocated to one of five treatment groups (approximately four participants per group) that