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FDA Approves Xtoro (Finafloxacin) to Treat Swimmer’s Ear

Newest fluoroquinolone to win agency’s okay

The FDA has approved Xtoro (finafloxacin otic suspension, Alcon Laboratories), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.

            Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria in the ear canal. Activities in which the ear is underwater can create a moist environment in which bacteria may sometimes grow. The infection causes inflammation of the ear canal leading to pain, swelling, redness of the ear, and discharge from the ear.

            Xtoro is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved by the FDA. It joins several other antibacterial drug products previously approved to treat ear infections.

            The safety and efficacy of Xtoro were primarily established in two clinical trials in which 1,234 participants between the ages of 6 months and 85 years were randomly assigned to receive Xtoro or its vehicle (a solution without a fluoroquinolone). Clinical cure was achieved if the ear tenderness, redness, and swelling were completely resolved.

            Among 560 participants whose acute otitis externa was confirmed to be caused by P. aeruginosa or S. aureus, 70% of those who received Xtoro achieved clinical cure compared with 37% of those who received the vehicle. In addition, Xtoro was superior to the vehicle for clearing the bacteria based on ear culture, and eased ear pain sooner than the vehicle.

            The most common side effects reported in Xtoro-treated subjects were pruritus of the ear and nausea.

            Source: FDA; December 17, 2014.

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