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FDA approves Otiprio for swimmer’s ear
Otonomy Inc. announced that it has received FDA approval for Otiprio 6% to treat acute otitis externa caused by Staphylococcus aureus and Pseudomonas aeruginosa in patients aged older than 6 months.
The product is the first single-dose antibacterial to receive FDA approval for treating acute otitis externa, according to a press release.
Otiprio is also approved for bilateral otitis media with effusion in patients undergoing tympanostomy tube placement, according to the company. The product is a sterile, preservative-free, otic suspension of 6% ciprofloxacin given as a single-dose. It is a liquid at or below room temperature and turns to a gel when warmed. The dosage varies based on the condition being treated.
“This approval is an important milestone ... it broadens the target physician population beyond otolaryngologists to pediatricians and primary care physicians who treat the vast majority of acute otitis externa cases,” David A. Weber, PhD, president and CEO of Otonomy Inc., said in the press release. “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 health care professional and then billed using an existing J Code.”
The company stated that a phase 3 trial in patients with acute otitis externa showed a "statistically significant clinical response," that is, the complete removal of signs and symptoms such as otorrhea, edema, erythema and tenderness compared with placebo. In addition, two phase 3 trials involving patients with bilateral otitis media with effusion showed that a single intraoperative dose of Otiprio allowed for “a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone,” (P scores for both trials < .001).
Adverse events for those who received Otiprio for acute otitis externa included ear discomfort, ear pruritus, headache, and otitis media. These took place in at least 2% of the patients, according to the release. Adverse events that occurred in at least 3% of the patients who received Otiprio for bilateral otitis media were rhinorrhea, irritability and nasopharyngitis.
Disclosure: Weber works for Otonomy Inc.