Daré Bioscience Inc (NASDAQ: DARE) has received clearance from the FDA for its investigational new drug (IND) application for DARE-VVA1. This non-hormonal treatment option is aimed at addressing moderate to severe dyspareunia, a symptom of vaginal atrophy associated with menopause.
Dyspareunia, or painful intercourse, is a common symptom experienced by postmenopausal women due to vaginal atrophy. Vaginal atrophy is characterized by inflammation and thinning of the vaginal epithelium caused by reduced levels of circulating estrogen. Typical symptoms include vaginal dryness, itching, burning, and painful intercourse.
With the IND clearance from the FDA, Daré can now proceed with planning for a Phase 2 clinical study of DARE-VVA1. The study will be randomized, double-blinded, placebo-controlled, and will focus on finding the optimal dose for the treatment.
DARE-VVA1 is an investigational formulation of tamoxifen designed for intravaginal administration. Tamoxifen is commonly used in the treatment of breast cancer, but Daré is exploring its potential for addressing dyspareunia associated with vaginal atrophy.
This IND clearance is a significant regulatory milestone for Daré, as it allows the company to continue advancing its innovative product candidates and addressing unmet needs in women’s health. Sabrina Martucci Johnson, President and CEO of Daré, commented on the importance of this milestone and its impact on the company’s strategic discussions.
“While we do not plan to commence the Phase 2 study until after we secure additional capital, this IND clearance marks an important regulatory step for Daré that supports our strategic discussions as we advance our portfolio of innovative product candidates and strive to address some of women’s most persistent unmet needs,” said Johnson.
In terms of market reaction, Daré’s shares have experienced a slight dip following the announcement. As of the last check on Thursday, DARE shares were down 3.74% at $0.33.
The clearance of Daré’s IND application for DARE-VVA1 is a positive development for the company and represents progress in its mission to provide innovative solutions for women’s health. As the company moves forward with its Phase 2 study, it holds the potential to offer a much-needed non-hormonal treatment option for women experiencing dyspareunia associated with menopause.
