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