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FDA approves Xtoro for acute otitis externa
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The FDA today announced the approval of a finafloxacin otic suspension for the treatment of acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus.
The finafloxacin otic suspension (Xtoro, Alcon Laboratories) is the newest drug within the fluoroquinolone antimicrobial drug class approved by the FDA, according to a press release.
The FDA based its approval on two trials designed to assess clinical safety and efficacy of the suspension in 1,234 participants aged 6 months to 85 years. Study participants were randomly assigned to receive finafloxacin otic suspension or a solution without a fluoroquinolone.
Clinical cure was achieved by 70% of study participants who received the finafloxacin otic suspension and were confirmed to have acute otitis externa caused by P. aeruginosa or S. aureus vs. 37% of those who received a solution without a fluoroquinolone.
Edward Cox
According to an FDA press release, Xtoro was superior to the vehicle for clearing the bacteria based on ear culture and eased ear pain sooner than the vehicle.
Itching of the ear and nausea were the most commonly reported side effects.
“The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs,” Edward Cox, MD, MPH, director of the FDA’s office of antimicrobial products, said in the release.