This is the first single-dose antibacterial approved for treating AOE.
The US Food and Drug Administration (FDA) has approved Otonomy, Inc.’s ciprofloxacin otic suspension 6% (Otiprio) for the treatment of acute otitis externa (AOE) in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus.
The approval is backed by positive results from a pivotal phase 3 clinical trial in 262 pediatric and adult patients with AOE. The single administration of Otiprio met its primary endpoint defined as the complete absence of signs and symptoms of AOE, tenderness, erythema, edema and otorrhea versus the placebo.
“This approval is an important milestone for the Otiprio program because it significantly expands the product’s commercial potential to include approximately 4 million episodes of AOE per year in the US, and broadens the target physician population beyond otolaryngologists to pediatricians and primary care physicians who treat the vast majority of AOE cases,” David Weber, PhD, president, chief executive officer, Otonomy said in statement.
Otiprio, a sterile, preservative-free otic suspension of 6% ciprofloxacin, is administered as a single 0.2 mL (12 mg) administration to the external ear canal of the affected ear(s).
“This indication also provides an entry point for Otiprio use in the office setting where the single-dose treatment can be administered by a physician or healthcare professional and then billed using an existing J Code,” Weber added.
Overall, Otiprio was well tolerated. Adverse effects with an incidence at least 2% that occurred versus the placebo were ear pruritus (2% vs. 2%), headache (2% vs. 1%), otitis media (2% vs. 1%) and ear discomfort (2% vs. 0%).
The safety and effectiveness in infants younger than 6 months of age have not been established.
Otiprio, a fluoroquinolone antibacterial, is also indicated for the treatment of pediatric patients 6 months of age and older with bilateral otitis media with effusion undergoing tympanostomy tube replacement.
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