Daré’s Xaciato (clindamycin phosphate) Vaginal Gel Receives the US FDA’s Approval for the Treatment of Bacterial Vaginosis
Shots:
- The approval was based on the P-III (DARE-BVFREE) study to evaluate the efficacy and safety of Xaciato vs PBO in a ratio (2:1) in 307 patients aged ≥12yrs. with bacterial vaginosis. The therapy is expected to be available in the US in 2022
- The results showed that Xaciato was superior to PBO in the ITT population at day 21-30, patients clinically cured (70.5% (86/122) vs 35.6% (21/59) while patients achieved clinical cure (76.0% vs 23.7%) on Day 7-14
- The therapy is administered via a user-filled disposable applicator delivering 5g of gel containing 100mg of clindamycin & has received both QIDP & FD designations from the US FDA for the treatment of bacterial vaginosis
Ref: Globe Newswire | Image: Darébio
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