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For the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement

Efficacy

Important Safety Information and Indications

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

OTIPRIO (ciprofloxacin otic suspension) 6% is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO

Two Multicenter Phase 3 Trials

Study design

Two Phase 3 randomized, controlled, blinded, multicenter studies compared the efficacy and safety of OTIPRIO with tubes vs tubes alone* in pediatric patients (N=532) with bilateral middle ear effusion requiring ear tube placement.

The median age of patients enrolled in the clinical trials was 1.5 years; 62% of patients were 6 months through 2 years of age and 38% of patients were greater than 2 years of age

The primary endpoint in both trials was the cumulative proportion of study treatment failures through Day 15

Treatment failure was defined as 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

 

Treatment with OTIPRIO reduced failure rates

OTIPRIO demonstrated statistically significant lower rates of treatment failure compared with tubes alone (P<0.001)

Administration of OTIPRIO did not lead to impairment in hearing function, middle ear function, or tube patency by Day 29

 

OTIPRIO demonstrated less otorrhea and less use of additional antibacterial drugs

Graph does not include the following two components of treatment failure: missed visits or lost-to-follow-up

Treatment failure was defined as 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

Reason for failure was recorded as the earliest occurring treatment event. Patients were classified as a treatment failure due only to that component for the remainder of the study.

Otiprio Brochure

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  • *Tubes alone arm: patients received an administration of air (sham) during ear tube placement.
  • †Blinded assessor: an independent, blinded clinician who observed and reported otorrhea during scheduled follow-up visits.
 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

OTIPRIO (ciprofloxacin otic suspension) 6% is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO

WARNINGS AND PRECAUTIONS

Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of non-susceptible bacteria and fungi. If such infections occur, institute alternative therapy.

ADVERSE REACTIONS

Bilateral otitis media with effusion clinical trials: Adverse reactions (incidence at least 3%) with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).

Acute otitis externa clinical trial: Adverse reactions (incidence at least 2%) with OTIPRIO vs sham were: ear pruritus (2% vs 2%), headache (2% vs 1%), otitis media (2% vs 1%), and ear discomfort (2% vs 0%).

USE IN SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement and acute otitis externa.

INDICATIONS AND USAGE

OTIPRIO (ciprofloxacin otic suspension) 6% is a fluoroquinolone antibacterial indicated for:

  • The treatment of pediatric patients (6 months of age and older) with bilateral otitis media with effusion undergoing tympanostomy tube placement
  • The treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus