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Antibacterial Otiprio Approved for Use in Tube Placement for Otitis Media With Effusion

First product to receive FDA approval for this indication in children

The FDA has approved Otiprio (ciprofloxacin otic suspension, Otonomy, Inc.) for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement (TTP).

Otiprio is a single-dose fluoroquinolone antibacterial agent and the first product approved by the FDA for this indication. It is administered by a physician as a single 0.1-mL (6-mg) intratympanic administration into each affected ear after suctioning of the middle-ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.

In two phase 3 trials, a single intraoperative administration of Otiprio demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared with tubes alone (P < 0.001).

According to the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF), TTP surgery is the most common ambulatory surgery performed on children. Overall, approximately 1 million TTP procedures are performed each year in the U.S., of which 85% are in pediatric patients, who typically have middle-ear effusion and receive bilateral tubes. The tubes are placed for the treatment of persistent or recurrent otitis media. Placement of the tube helps to ventilate the middle ear and allows the administration of topical antibiotics to treat the infection.

Source: Otonomy, Inc., December 11, 2015.

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