Efficacy and Safety of Finafloxacin Otic Suspension, 0.3% for the Treatment of Acute Otitis Externa: Results from two Phase III Randomized Clinical Studies.

Abstract

Objective: Evaluation of the clinical efficacy and safety of finafloxacin otic suspension in 2 Phase III clinical trials, in patients 6 months or older, reflective of the populations at risk for acute otitis externa (AOE).

Methods: Two identical multicenter, randomized, double-masked, vehicle-controlled prospective Phase III studies in which 1234 patients (≥6 months) with AOE of presumed bacterial origin were randomized at 128 sites in the United States and Canada. Patients received finafloxacin otic suspension or vehicle twice daily for 7 days. The primary efficacy endpoint was the proportion of patients with clinical cure (resolution of tenderness, erythema and edema) on day 11 in the pathogen positive subset of the intention to treat (ITT) population.

Results: Patients of the pathogen positive subset of the ITT population treated with finafloxacin had a clinical cure rate of 70.2% on day 11 (test of cure visit, ToC) compared to 36.6% in the vehicle group (P < .0001). A comparable effect was observed in the ITT population (finafloxacin 71% cure vs vehicle 49.8%). Finafloxacin eradicated the most common AOE pathogens with high efficiency: 89% for Staphylococcus aureus and 85.3% for Pseudomonas aeruginosa (39.2% and 26.8% in the vehicle group, respectively). Median time to cessation of ear pain was 3.5 days in the finafloxacin group versus 7.0 days in the vehicle group (P < .0001), and thus markedly shorter than durations reported for other otic therapies. Finafloxacin had a safety profile comparable to that of vehicle. Adverse events-primarily ear pruritus, ear discomfort, and dizziness-occurred at similar rates in both groups.

Conclusions: Finafloxacin otic suspension was statistically superior to vehicle in clinical cures, pathogen eradication, and median time to ear pain resolution. It also demonstrated high efficacy against the primary AOE pathogens, S. aureus and P. aeruginosa, including fluoroquinolone-resistant pathogens. Finafloxacin was well-tolerated with a safety profile equivalent to vehicle.Clinical trial registry name:ClinicalTrials.gov; URL: https://clinicaltrials.gov/Identifier:NCT01535599 and NCT01535560.