Otiprio (ciprofloxacin otic suspension)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December 2015

Specific Treatments:

pediatrics with bilateral otitis media with effusion undergoing tympanostomy tube placement

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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.

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 Results

FDA Approval

The FDA approval of Otiprio was based on two phase III randomized, multicenter, controlled clinical trials in 532 pediatric patients with bilateral otitis media with effusion undergoing myringotomy with tympanostomy tube placement. The efficacy endpoint 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 3 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).

Side Effects

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

  • nasopharyngitis
  • irritability

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. 

Additional Information

For additional information regarding Otiprio or bilateral otitis media with effusion in pediatrics undergoing tympanostomy tube placement, please visit http://otiprio.com/