Xtoro approved for swimmer's ear

December 19, 2014

FDA has approved finafloxacin (Xtoro, Alcon) otic suspension for the treatment of otitis externa.

FDA has approved finafloxacin (Xtoro, Alcon) otic suspension for the treatment of otitis externa.

FDA drug approvals-December 2014

Otitis externa, commonly known as swimmer’s ear, is an inflammation or infection of the external auditory canal. It usually presents as an acute bacterial infection, most commonly attributable to Pseudomonas aeruginosa or Staphylococcus aureus, but can be caused by other bacteria, viruses or a fungal infection. Repeated exposure to water creates a moist environment where bacteria can grow. The infection causes inflammation of the ear canal leading to pain, swelling, redness, and discharge from the ear. Prompt diagnosis and appropriate therapy cures the majority of cases; however, an untreated patient may develop a more serious infection and complications. 

Xtoro is a fluoroquinolone antimicrobial indicated to treat otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. It is dispensed as an otic suspension for topical administration and joins several other antibacterial drug products previously approved to treat ear infections.

Read more on antibiotics

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

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The safety and efficacy of Xtoro were established in a clinical study of 1,234 people, aged 6 months to 85 years, assigned to receive either the medication or its vehicle, a solution without a fluoroquinolone. Among the 560 participants whose infection was caused by Pseudomonas aeruginosa or Staphylococcus aureus, 70% of the patients who received Xtoro achieved a clinical cure, compared to 37% of those who received the vehicle alone. Ear pruritis, or itching, and nausea, were the most common adverse events associated with using this drug.

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.