Otonomy announced that the Food and Drug Administration (FDA) has approved Otiprio (ciprofloxacin otic suspension) for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.
Otiprio otic suspension is physician-administered following suctioning of the middle ear effusion. It is the first treatment for this indication that is FDA approved. It utilizes a proprietary drug delivery technology that combines a thermosensitive gel with drug microparticles to allow for a single dose therapy. Otiprio exists as a liquid at, or below room temperature, and gels when warmed.
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The approval of Otiprio was based on two Phase 3 trials where a single intraoperative administration of Otiprio showed a statistically significant reduction in the cumulative proportion of study treatment failures vs. tubes alone (P<0.001). Otiprio is a fluoroquinolone antibiotic that works by interfering with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA.
Otiprio otic suspension will be available as a preservative-free 6% (60mg/mL w/v) strength suspension. Each carton contains 1mL of ciprofloxacin in a 2mL single-use vial. It is anticipated to launch in the first quarter of 2016.
For more information call (800) 826-6411 or visit Otiprio.com.