FDA Approves New Swimmer's Ear Treatment

The US Food and Drug Administration (FDA) approved today Xtoro (finafloxacinotic suspension), a novel drug treatment for acute otitis externa, otherwise known as swimmer’s ear, an infection within the outer ear and ear canal, typically caused by bacteria festered in the ear canal.

Xtoro eardrop is the latest addition to the fluoroquinolone antimicrobial drug class to be approved by the FDA.

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

Experts focused their research on monitoring the safety and efficacy of Xtoro by administering 2 clinical trials among a total of 1,234 randomly selected individuals aged 6 months to 85 years who received Xtoro itself or the eardrop’s vehicle solution without fluoroquinolone. Their goal was to gauge whether ear tenderness, redness, and swelling were found to be completely eradicated.

Xtoro-treated participants reported that the most common side effects were ear itchiness (pruritis) and nausea.

Study results found that among 560 patients, 70% receiving Xtoro successfully achieved the clinical cure as compared with the 37% who received the vehicle. They also noted that compared with the vehicle, Xtoro was reported to successfully “clear the bacteria based on ear culture, and eased ear pain sooner than the vehicle”.