FDA News

FDA approves antibacterial Otiprio for pediatric patients requiring ear tubes

Otonomy recently announced FDA approval of its Otiprio antibacterial treatment for pediatric patients with bilateral otitis media with effusion who undergo tympanostomy tube surgery, according to a press release.

“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,” David A. Weber, PhD, president and CEO of Otonomy, said in the release.

Otiprio (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial administered as a single 0.1 mL (6 mg) intratympanic dose directly into the affected ears, after suctioning of the middle ear effusion has been performed.

The FDA approval was based on two, prospective, multicenter, open-label phase 3b clinical trials with a cohort of approximately 500 patients, aged 6 months to 17 years, the release said. Ciprofloxacin otic suspension significantly reduced the overall proportion of tympanostomy tube treatment failures compared with tube treatments alone (P < .001).

“As someone who routinely sees young children suffering with persistent ear infections and performs hundreds of tube surgeries each year, I welcome the approval of Otiprio as the first FDA-approved product for this indication,” Eric A. Mair, MD, director of pediatric ENT at Levine Children’s Hospital, North Carolina, said in the release. “Being able to administer a single dose of Otiprio during the procedure gives me the assurance of antibiotic dosing which the phase 3 trials demonstrate reduces the rate of treatment failure following surgery.”

Ciprofloxacin otic suspension is the first treatment approved by the FDA for this indication, the release said. The treatment is expected to be available early next year.

Otonomy recently announced FDA approval of its Otiprio antibacterial treatment for pediatric patients with bilateral otitis media with effusion who undergo tympanostomy tube surgery, according to a press release.

“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,” David A. Weber, PhD, president and CEO of Otonomy, said in the release.

Otiprio (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial administered as a single 0.1 mL (6 mg) intratympanic dose directly into the affected ears, after suctioning of the middle ear effusion has been performed.

The FDA approval was based on two, prospective, multicenter, open-label phase 3b clinical trials with a cohort of approximately 500 patients, aged 6 months to 17 years, the release said. Ciprofloxacin otic suspension significantly reduced the overall proportion of tympanostomy tube treatment failures compared with tube treatments alone (P < .001).

“As someone who routinely sees young children suffering with persistent ear infections and performs hundreds of tube surgeries each year, I welcome the approval of Otiprio as the first FDA-approved product for this indication,” Eric A. Mair, MD, director of pediatric ENT at Levine Children’s Hospital, North Carolina, said in the release. “Being able to administer a single dose of Otiprio during the procedure gives me the assurance of antibiotic dosing which the phase 3 trials demonstrate reduces the rate of treatment failure following surgery.”

Ciprofloxacin otic suspension is the first treatment approved by the FDA for this indication, the release said. The treatment is expected to be available early next year.