The Food and Drug Administration (FDA) has approved Xaciato™ (clindamycin phosphate) vaginal gel for the treatment of bacterial vaginosis in females 12 years of age and older.
Xaciato, a lincosamide antibacterial, is a thermosetting bioadhesive hydrogel containing clindamycin phosphate 2%. The product is administered via a user-filled disposable applicator delivering 5g of gel containing 100mg of clindamycin as a single dose.
The approval was based on data from the multicenter, randomized, double-blind, placebo-controlled phase 3 DARE-BVFREE study (ClinicalTrials.gov Identifier: NCT04370548), which evaluated the efficacy and safety of Xaciato in 307 patients aged 12 years and older diagnosed with bacterial vaginosis. Patients were randomly assigned 2:1 to receive a single vaginal dose of Xaciato (n=204) or placebo (n=103).
Xaciato was found to be statistically superior to placebo at the test of cure visit at day 21-30 in the intent-to-treat population (primary endpoint), with 70.5% (86/122) of patients clinically cured compared with 35.6% (21/59) for placebo. Clinical cure was defined as resolution of abnormal vaginal discharge associated with bacterial vaginosis, clue cells less than 20% of total epithelial cells on microscopy, and a negative 10% KOH whiff test. Among the subsets of patients defined by prior episodes of bacterial vaginosis (3 episodes or less and greater than 3 episodes in the previous 12 months), 71.3% (72/101) and 70% (14/20) of patients, respectively, in the Xaciato arm achieved clinical cure at the test of cure visit compared with 39.1% (18/46) and 23.1% (3/13) of patients in the placebo arm.
The most common adverse reactions reported in greater than 2% of patients and at a higher rate in the Xaciato arm were vulvovaginal candidiasis and vulvovaginal discomfort.
Xaciato is supplied as a clear, colorless, viscous gel in a carton containing a 25g tube of vaginal gel and 1 vaginal applicator. It is expected to be available in 2022.
- Daré announces FDA approval of Xaciato™ (clindamycin phosphate) vaginal gel as a treatment for bacterial vaginosis. News release. Daré Bioscience, Inc. Accessed December 7, 2021. https://www.globenewswire.com/news-release/2021/12/07/2347833/30757/en/Dar%C3%A9-Announces-FDA-Approval-of-XACIATO-clindamycin-phosphate-Vaginal-Gel-as-a-Treatment-for-Bacterial-Vaginosis.html.
- Xaciato. Package insert. Daré Bioscience, Inc.; 2021. Accessed December 7, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215650s000lbl.pdf.