Business
Daré Announces FDA Approval of XACIATO™ (clindamycin phosphate) Vaginal Gel as a Treatment for Bacterial Vaginosis
Prescribing information supports positioning of XACIATO as a first line option for the treatment of bacterial vaginosisThis marks the first FDA-approved
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Prescribing information supports positioning of XACIATO as a first line option for the treatment of bacterial vaginosisThis marks the first FDA-approved product in Daré’s portfolio of potential first in category development candidates 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 (GLOBE NEWSWIRE) -- 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 that gives healthcare providers clear insights into how to use XACIATO in those patient populations in greatest need of a therapeutic option, such as pregnant women and women with recurrent episodes of bacterial vaginosis. 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 f...