General Information

Xtoro is specifically indicated for the treatment of acute otitis externa caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus.

Mechanism of Action

Xtoro (finafloxacin otic suspension 0.3 percent) is a fluoroquinolone antimicrobial. The fluoroquinolone class of antibacterials inhibit bacterial type II topoisomerase enzymes, DNA gyrase and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair and recombination.

Side Effects

Adverse effects associated with the use of Xtoro may include, but are not limited to, the following:

• Ear pruritus
• Nausea

Dosing/Administration

Xtoro is supplied as a solution for topical administration. The recommended initial dose is as follows: Instill four drops in the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to eight drops), followed by four drops instilled into the affected ear twice daily for seven days.

Clinical Trial Results

FDA Approval

The FDA approval of Xtoro was based on two randomized multicenter, vehicle-controlled clinical trials. Xtoro dosed four drops twice daily for seven days was superior to its vehicle for both clinical and microbiological outcomes, as well as in time to cessation of ear pain in patients with acute otitis externa. Among 560 patients (161 with an otowick) that were pathogen positive (baseline microbiological specimen that contained Staphylococcus aureus and/or Pseudomonas aeruginosa), clinical cure on Day 11 was 71 percent in Xtoro versus 37 percent in vehicle. Among 1,234 patients who received study treatment (Intent to Treat population [ITT]), ages 6 months to 85 years, clinical cures were 71 percent for Xtoro and 50 percent in vehicle.