FDA approves ciprofloxacin otic suspension for children undergoing tympanostomy tube placement
Wed, 23 Dec 2015
This is from medscape- FYI:
The US Food and Drug Administration (FDA) has approved ciprofloxacin otic suspension (Otiprio, Otonomy, Inc) for children with bilateral otitis media with effusion undergoing tympanostomy tube placement.
After suctioning of the middle ear effusion, ciprofloxacin is administered by a physician as a single 0.1-mL (6 mg) intratympanic administration into each affected ear. "The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed," the company explained in a news release.
In two phase 3 trials, a single intraoperative administration of ciprofloxacin showed a statistically significant reduction in the cumulative proportion of study treatment failures compared with tube placement alone (P < .001).
Adverse reactions (incidence at least 3%) that occurred in phase 3 trials with ciprofloxacin vs sham were nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).
Otiprio is first product approved by the FDA for this indication, the company noted in the release.
"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 Mair, MD, from Charlotte Eye Ear Nose and Throat Associates in 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."
Tympanostomy tube placement is the most common ambulatory surgery performed on children, according to the American Academy of Otolaryngology-Head and Neck Surgery Foundation, with roughly 1 million procedures performed annually in the United States, most in children. The tubes help ventilate the middle ear and allow for administration of topical antibiotics to treat infection.
Otiprio is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of Otiprio. It may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, alternative therapy should be used, the company said.
The safety and effectiveness of ciprofloxacin otic suspension in infants younger than 6 months of age have not been established, they noted.