Efficacy and Safety of Finafloxacin Otic Suspension, 0.3% for the Treatment of Acute Otitis Externa: Results from two Phase III Randomized Clinical Studies.
Ann Edmunds, Christine Bentley, Mark Lückermann et al.
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In 30 seconds
This study evaluated the efficacy and safety of finafloxacin otic suspension (0.3%) in treating acute otitis externa (AOE) in patients aged 6 months and older through two Phase III randomized controlled trials. Finafloxacin demonstrated a clinical cure rate of 70.2% compared to 36.6% for the vehicle group (P < .0001), indicating significant superiority in treating AOE.
Key findings
- Finafloxacin achieved a clinical cure rate of 70.2% vs 36.6% in the vehicle group (P < .0001).
- Median time to cessation of ear pain was 3.5 days for finafloxacin compared to 7.0 days for the vehicle (P < .0001).
- Finafloxacin eradicated 89% of Staphylococcus aureus and 85.3% of Pseudomonas aeruginosa.
- The safety profile of finafloxacin was comparable to that of the vehicle.
Why it matters
The findings suggest that finafloxacin otic suspension is an effective treatment option for acute otitis externa, particularly in eradicating common pathogens and reducing pain duration, which may improve patient outcomes.