FDA Clears Finafloxacin Ear Drops (Xtoro) for Swimmer's Ear

Megan Brooks

December 17, 2014

Editor's note: Alcon, the company that makes Xtoro, confirmed to Medscape Medical News on December 18 that it does not plan to market Xtoro in the United States. No explanation was given, other than the statement, "We continuously evaluate long-term growth opportunities within our product portfolio."

The US Food and Drug Administration (FDA) has approved the fluoroquinolone antimicrobial, finafloxacin otic suspension (Xtoro, Alcon Labs), to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus.

Commonly known as swimmer's ear, acute otitis externa is an infection in the outer ear and ear canal typically caused by bacteria in the ear canal. Swimming and other activities in which the ear is underwater can create a moist environment where bacteria may grow. The infection causes inflammation of the ear canal leading to pain, swelling, redness of the ear, and discharge from the ear.

Finafloxacin ear drops join several other antibacterial drug products previously approved to treat ear infections.

"The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs," Edward Cox, MD, MPH, director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

The safety and efficacy of finafloxacin otic suspension were demonstrated in two clinical trials involving 1234 participants between the ages of 6 months and 85 years. Participants were randomly assigned to receive finafloxacin otic suspension or a vehicle solution without a fluoroquinolone.

Among 560 participants whose acute otitis externa was confirmed to be caused by Pseudomonas aeruginosa or Staphylococcus aureus, 70% who received Xtoro achieved clinical cure, defined as complete resolution of ear tenderness, redness, and swelling compared with 37% who received the vehicle.

Finafloxacin otic suspension was also superior to the vehicle for clearing the bacteria based on ear culture and eased ear pain sooner than the vehicle.

The most common adverse effects reported with finafloxacin ear drops were pruritus and nausea.


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