General Information

Xaciato (clindamycin phosphate) vaginal gel is a lincosamide.

Xaciato is specifically indicated for the treatment of bacterial vaginosis in females 12 years and older.

Xaciato is supplied as a gel for topical administration. The recommended dosage of Xaciato is one applicatorful (5 g of vaginal gel containing 100 mg of clindamycin) administered once intravaginally as a single dose at any time of the day.

Mechanism of Action

Clindamycin is an antibacterial drug. Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is predominantly bacteriostatic. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts it to active clindamycin.

Side Effects

Adverse effects associated with the use of Xaciato may include, but are not limited to, the following:

• vulvovaginal candidiasis
• vulvovaginal discomfort

Clinical Trial Results

FDA approval was based on a randomized, double-blind, placebo-controlled clinical study. A single dose of Xaciato (clindamycin phosphate vaginal gel, 2%) was compared to a single dose of placebo vaginal gel (hydroxyethylcellulose [HEC] Universal Placebo Gel) for the treatment of BV. Patients were evaluated at 3 timepoints: a Day 1 screening/randomization visit, a Day 7 to 14 Interim Assessment visit, and a Day 21 to 30 Test of Cure visit. The total study duration was up to approximately 1 month for each individual patient. Clinical Cure was defined as resolution of the abnormal vaginal discharge associated with BV, a negative 10% KOH whiff test, and clue cells < 20% of the total epithelial cells in the saline wet mount. Bacteriological Cure was defined as a Nugent score < 4. Therapeutic Cure was defined as the presence of both a Clinical Cure and Bacteriological Cure. In the mITT population, a statistically significantly greater percentage of patients experienced Clinical Cure, Bacteriological Cure, and Therapeutic Cure at the Test of Cure (Day 21-30) visit in the Xaciato arm compared to placebo. Statistically significant results for the endpoints were also achieved at the Interim Assessment visit (Day 7-14).