Regulatory Decision Summary for XTORO

Health Canada considers that the benefit/risk profile of Xtoro (finafloxacin otic suspension), 0.3% is favorable for the treatment of acute otitis externa (AOE) caused with susceptible strains of Staphylococcus aureus and Pseudomonas aeruginosa, with or without an otowick, in patients age 1 year and older.

The efficacy and safety of Xtoro was evaluated in two randomized, multicentre, vehicle-controlled clinical trials. The primary efficacy endpoint in these studies was the proportion of patients who achieved clinical cure as defined by resolution of signs and symptoms of AOE (tenderness, erythema, and edema) as well as cessation of pain. Microbiological success was defined as the absence of pre-therapy bacteria from the exit otic specimen obtained on Day 11. Xtoro was dosed twice daily for 7 days. Each study met its primary efficacy endpoint. Xtoro was superior to the vehicle (the topical comparator) in the proportion of patients who achieved clinical cure in the pathogen-positive subset of patients. Among patients (including those with an otowick) that were pathogen-positive (baseline microbiological specimen that contained Staphylococcus aureus and/or Pseudomonas aeruginosa), the clinical cure on Day 11 was 72% and 69% in the Xtoro groups versus 33% and 40% in the vehicle groups. The time to cessation of ear pain in patients treated was shorter by 2.5 days with Xtoro as compared with vehicle control.

Xtoro was well tolerated and the adverse drug reaction profile was comparable with the vehicle control. Adverse events reported by greater than or equal to 1% of patients and more frequently in the Xtoro group were ear pruritius, otitis externa, and nausea. No additional risks were identified with the use of Xtoro relative to its vehicle and the known risks of the fluoroquinolone-containing marketed otic products.

In conclusion, the clinical benefits of Xtoro as treatment for AOE in patients age 1 year and older outweigh the risks under the conditions of use described in the Product Monograph.

For more information on Health Canadas decision, please view the Summary Basis of Decision.