Vaginal Gel Approved for Bacterial Vaginosis
The FDA approved clindamycin phosphate vaginal gel, 2% (Xaciato), for the treatment of bacterial vaginosis in females 12 years of age and older. The gel is delivered by a user-filled disposable applicator.
The drug, a lincosamide antibacterial, is a thermosetting bioadhesive hydrogel containing clindamycin phosphate 2%. The user-filled disposable applicator delivers 5 g of gel containing 100 mg of clindamycin as a single dose.
The FDA based its decision to approve clindamycin phosphate vaginal gel on data from a phase 3 clinical trial that evaluated the efficacy and safety of the drug in 307 patients aged 12 years and older diagnosed with bacterial vaginosis. Patients were randomly assigned 2:1 to receive a single dose of the drug or placebo. Clindamycin phosphate vaginal gel was found to be statistically superior to placebo with respect to clinical cure (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).
The most common adverse reactions reported in more than 2% of patients were vulvovaginal candidiasis and vulvovaginal discomfort.
Xaciato is a product of Daré Bioscience, Inc. Consult product labeling for full prescribing information.