• This marks the first FDA-approved product in Daré’s portfolio of potential first in category development candidates
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• Strategic partnering discussions ongoing; Conference call will be scheduled once a definitive partnership agreement for commercialization of XACIATO in the U.S. is finalized and executed; U.S. commercial launch expected 2022

SAN DIEGO, Dec. 07, 2021 -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) approved XACIATO [zah-she-AH-toe] (clindamycin phosphate vaginal gel, 2%) (formerly known as DARE-BV1) for the treatment of bacterial vaginosis in females 12 years of age and older.

“The FDA approval of XACIATO 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 as a company to accelerate the development of differentiated products that can improve outcomes and convenience for women. In the case of XACIATO, this FDA approval comes just three years after we licensed this technology. We are grateful to the FDA for their thoughtful review and the alignment on labeling.  We hope that this is the first of many FDA approvals in our efforts to improve the lives of women with treatment options that address some of the most persistent unmet needs.”

“Bacterial vaginosis is not a sexually transmitted infection, but rather an overgrowth of bacteria naturally found in the vagina, which upsets the balance of the natural vaginal microbiome and leads to not only distressing symptoms of odor and discharge, but also increases a woman's risk of preterm birth, infertility, and infections.  Today, approximately half of the women treated for bacterial vaginosis experience a recurrence within 12 months of treatment.  There is a need for more efficacious and convenient treatment options, particularly products with improved clinical outcomes for not only the newly diagnosed women, but, importantly, also for the women who experience multiple episodes of bacterial vaginosis each year,” said David Friend, Ph.D., Daré’s Chief Scientific Officer. “Now that we have achieved this important demonstration of this drug delivery hydrogel platform technology, we are actively exploring the opportunity to leverage it across other unmet needs in women's health.”

About XACIATOTM (clindamycin phosphate) Vaginal Gel

XACIATO is the trade name for clindamycin phosphate vaginal gel, 2%. XACIATO is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. XACIATO is a clear, colorless, viscous gel, which contains clindamycin at a concentration of 2% (present as clindamycin phosphate). A single-dose user-filled disposable applicator delivers 5 g of vaginal gel containing 100 mg of clindamycin. The New Drug Application (NDA) for XACIATO was approved by the FDA on December 7, 2021. 

The NDA was supported by positive results from the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating XACIATO in women diagnosed with bacterial vaginosis (NCT04370548).

XACIATO received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis. As a result of the QIDP designation, XACIATO is expected to receive a five-year extension of the three years of market exclusivity available to the product based on the submission of new clinical data that were essential to its approval. Strategic partnering discussions and other activities intended to support a robust market introduction of XACIATO in 2022 in the United States are ongoing and a conference call to discuss the partnership and market introduction strategy will be scheduled once a definitive partnership agreement is finalized and executed.

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