FDA Approves New Drug for Swimmer's Ear

The FDA today approved finafloxacin otic suspension (Xtoro), a new drug used to treat acute otitis externa, an outer ear and ear canal infection that is also known as swimmer’s ear.

The eardrop from Alcon Laboratories treats acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus, which leads to pain, swelling, redness of the ear, and discharge from the ear.

Xtoro is the newest member of the fluoroquinolone antimicrobial drug class to receive FDA approval, and it joins 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,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release.

Xtoro’s safety and efficacy were primarily established in 2 clinical trials that randomly assigned 1234 patients aged between 6 months and 85 years to receive Xtoro or a solution without a fluoroquinolone. Of the 560 participants whose acute otitis externa was confirmed to be caused by either 1 of the 2 aforementioned bacteria, 70% of those taking Xtoro saw their ear tenderness, redness, and swelling completely resolve, compared with 37% who received the other solution.

Xtoro was also superior for clearing the bacteria based on ear culture, and it eased ear pain sooner. The most common side effects reported in Xtoro-treated participants were pruritis and nausea.