Daré Bioscience Announces FDA Acceptance & Priority Review of NDA for DARE-BV1 for the Treatment of Bacterial Vaginosis

Daré Bioscience, Inc. recently announced the US FDA accepted for filing the company’s New Drug Application (NDA) for DARE-BV1 for the treatment of bacterial vaginosis. The FDA granted this application Priority Review and set a Prescription Drug User Fee Act (PDUFA) date of December 7, 2021, for the target completion of its review of the NDA. The FDA grants Priority Review to applications for potential drugs that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition.

The NDA is supported by positive results from the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating DARE-BV1 in women diagnosed with bacterial vaginosis, a condition that can cause serious health risks and very disruptive symptoms and is estimated to affect approximately 21 million women in the US. DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% designed as a one-time vaginally-administered treatment for bacterial vaginosis.

“The acceptance of this NDA marks a major milestone not only for Daré as a company but importantly for the 21 million women impacted by bacterial vaginosis,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “It is our goal to bring to market a product that has the potential to improve outcomes and convenience for women, as DARE-BV1 demonstrated it has the potential to do in the Phase 3 study, where a single vaginal dose of DARE-BV1 achieved clinical cure rates of 70%-81%.”

The results from the DARE-BVFREE study demonstrated DARE-BV1’s potential to provide improved clinical cure rates in a convenient, one-time dose compared to those of currently branded FDA-approved products indicated for the treatment of bacterial vaginosis. Patients in the study were evaluated during three clinic visits: Day 1 (screening and randomization visit), Day 7-14 (assessment visit), and Day 21-30 (test-of-cure visit). The study met its primary endpoint, demonstrating that as a primary therapeutic intervention a single vaginal dose of DARE-BV1 was statistically superior to placebo at Day 21-30 in the modified intent-to-treat population (70% compared to 36% of subjects clinically cured). Additionally, DARE-BV1 demonstrated clinical cure rates of 77% at Day 21-30 and 81% at Day 7-14 in the per protocol population, compared to 43% and 30% for placebo cream, respectively. Current FDA-approved products have clinical cure rates in the range of only 37%-68%.

DARE-BV1 has received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis. Under QIDP designation, if approved, DARE-BV1 will receive 5 years of additional market exclusivity on top of the three years available for having generated new clinical data.

Ongoing strategic discussions and other activities intended to support a robust market introduction of DARE-BV1 in 2022, if approved, are underway in parallel with the regulatory process. The FDA’s target date for the completion of its review of December 7, 2021, aligns with Daré’s intent to finalize and announce the commercialization strategy for DARE-BV1 in the US in 2021. Commercialization arrangements for DARE-BV1 may include granting pharmaceutical companies with other commercial products in women’s health an out-license to exclusively market, sell, and distribute the product, if approved, in specific geographies; engaging commercial sales organizations to utilize their internal sales organizations and other commercial functions for market access, marketing, distribution, and other related services; or assembling a hybrid of these potential options to co-promote the product.

Information about the results from the DARE-BVFREE Phase 3 clinical study of DARE-BV1 currently can be found in the company’s most recent investor presentation under “Presentations, Events & Webcasts” in the Investors section of the company’s website at http://ir.darebioscience.com.

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 novel, hormone-free, monthly contraceptive whose US commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a proprietary 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 therapy following menopause. For more information, visit www.darebioscience.com.