Otiprio Approved for the Treatment of Acute Otitis Externa
The Food and Drug Administration (FDA) has approved Otiprio (ciprofloxacin otic suspension; Otonomy) 6% for the treatment of acute otitis externa (AOE) in patients ≥6 months old due to Pseudomonas aeruginosa and Staphylococcus aureus. Otiprio is a sterile, preservative-free, otic suspension that is administered as a single-dose to the external ear canal of each affected ear by a healthcare professional.
The approval was based on a randomized, multicenter, sham-controlled trial in 262 pediatric and adult patients with unilateral or bilateral AOE. Compared to sham, more patients in the Otiprio group had a clinical response (defined as the complete absence of signs and symptoms of AOE) at day 8 (intention to treat [ITT]: 69% vs. 46%,
% difference: 23.1 [P<0.001]; microbiological ITT: 60% vs 34%, % difference: 25.7 [P=0.012].
Otiprio is also indicated for intratympanic administration in pediatric patients (≥6 months) with bilateral otitis media with effusion undergoing tympanostomy tube placement.
Each carton of Otiprio contains 1mL of 6% (60mg/mL, w/v) ciprofloxacin, a fluoroquinolone antibacterial, in a 2mL single-patient use vial.
For more information visit Otiprio.com.