General Information

Otiprio is an oral suspension of ciprofloxacin, a fluoroquinolone antibacterial.

Otiprio is specifically indicated as a single-dose treatment for pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

Mechanism of Action

Otiprio is an oral suspension of ciprofloxacin, a fluoroquinolone antibacterial. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA. 

Side Effects

Adverse effects associated with the use of Otiprio may include, but are not limited to, the following:

• Nasopharyngitis
• Irritability

Dosing/Administration

Otiprio is supplied as a suspension for intratympanic administration. The recommended dose is a single intratympanic administration of one 0.1 mL (6 mg) dose into each affected ear, following suctioning of middle ear effusion.

Clinical Trial Results

FDA Approval

The FDA approval of Otiprio was based on two phase 3 randomized, multicenter, controlled clinical trials in 532 pediatric patients with bilateral otitis media with effusion undergoing myringotomy with tympanostomy tube placement. The efficacy end point for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after three days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery as well as patients who missed visits or were lost-to-follow-up. Data showed a single intraoperative administration of Otiprio demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).