The Food and Drug Administration has approved finafloxacin otic suspension to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus.
The suspension joins several other antibacterials already approved to treat swimmer’s ear.
“The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement .
Safety and efficacy were established in two studies. A total of 1,234 participants aged 6 months and 85 years were randomly assigned to receive finafloxacin or vehicle. About half had confirmed P. aeruginosa or S. aureus; of those 70% who were given finafloxacin had clinical cure, defined as complete resolution of ear tenderness, redness, and swelling. Patients who received the vehicle alone achieved a 37% cure rate.
Finafloxacin was also superior to the vehicle for clearing the bacteria and eased ear pain sooner, according to the FDA statement.
The most common side effects were ear pruritus and nausea.
Alcon Laboratories will market finafloxacin otic suspension as Xtoro.
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