Ear Inflammation Treatment Otiprio Approved for Children
The FDA has approved Otonomy's ciprofloxacin otic suspension for the treatment of bilateral otitis media with effusion in pediatric patients who are undergoing tympanostomy tube placement.
The FDA today approved Otonomy’s ciprofloxacin otic suspension (Otiprio) for the treatment of bilateral otitis media with effusion in pediatric patients who are undergoing tympanostomy tube placement.
The first product to receive the FDA’s nod for this indication, Otiprio is intratympanically administered by a physician as a single 0.1 ml dose. The drug is thermosensitive, maintaining a liquid state at or below room temperature and then solidifying into a gel when warmed.
The agency based its decision on safety and efficacy data from 2 late-stage trials in which the use of Otiprio yielded a statistically significant reduction in the cumulative proportion of treatment failures compared with tubes alone.
“The approval of Otiprio, our first product, is a landmark moment in the history of Otonomy, and provides important validation for our proprietary drug delivery technology that combines a thermosensitive gel with drug microparticles to enable single-dose treatment by a physician,” said Otonomy president and CEO David A. Weber, PhD, in a press release.
The most common adverse events reported include nasopharyngitis, irritability, and rhinorrhea.
Otiprio is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the drug’s components.
Additionally, the drug’s safety and efficacy in patients younger than 6 months has not yet been established.
Otonomy plans to launch Otiprio in the first quarter of 2016.