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OTIPRIO (ciprofloxacin otic suspension)--A paradigm shift in management of otitis media with effusion requiring tympanostomy tubes in pediatric patients.

Prevalence

Tympanostomy tubes (TT) is one of the most common pediatric surgeries. By the age of 3. about 1 in 15 children will have ear tubes. (1)

Current approach for otitis media with effusion (OHE) at the time of TT

Your current approach may be aspiration of the fluid through tube placement in the anterior/inferior quadrants followed by administration of antibiotic drops of choice. This will likely rely on parents or adults to provide continuation of the drops by administering them into the child's ears at home multiple times per day for a number of days post-operatively.

A different approach

OTIPRIO. an antibiotic for the treatment of pediatric patients (age 6 months to 17 years) with bilateral OME undergoing TT is the first and only single-dose ciprofloxacin otic suspension administered by an ENT at the time of tube placement.

Thermosensitive liquid-to-gel technology

With its thermosensitive technology. OTIPRIO transitions from a liquid to a gel when warmed. At temperatures below normal human body temperature. OTIPRIO remains in a liquid state. When administered directly into the middle ear at the time of surgery, OTIPRIO quickly gels upon contact in the middle ear mucosa, coating the surfaces underneath the tympanic membrane. The ciprofloxacin particles remain in the middle ear with the gel delivery vehicle disappearing over time.

100% assured compliance

Administration of OTIPRIO. as a single-dose application, is performed by the surgeon and leads to 100% compliance no longer leaving treatment application in the hands of parents. In a recent study, it was revealed that 55% of parents missed or forgot to give the antibiotic otic drops to their awake/active child at home. (2) OTIPRIO also eliminates the need for adults to struggle getting drops down the external auditory canal and to wonder if the drops got through the child's TT opening.

OTIPRIO should be considered as an alternate therapy in your surgical toolbox

To date, over 400 institutions in the U.S. have utilized OTIPRIO in their TT cases. OTIPRIO is the first single dose, physician administered product approved by the FDA for the treatment of pediatric patients with bilateral otitis media with effusion undergoing TT placement.

Proven in clinical trials

Two identical, prospective, double-blind, sham-controlled, multicenter. Phase 3, randomized trials comparing the efficacy, safety, and tolerability

of OTIPRIO with TT vs TT alone (sham) were conducted in pediatric patients with bilateral middle ear effusion requiring tube placement (N=532). (3) 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. OTIPRIO demonstrated statistically significant lower rates of treatment failure compared with TT alone. Administration of OTIPRIO did not lead to impairment in hearing function, middle ear function, or tube patency by Day 29.

Important safety information

OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO. There is a warning and precaution for the potential overgrowth of nonsuceptible bacteria and fungi with use of OTIPRIO. If such infections occur, institute alternative therapy. In pivotal trials, adverse reactions that occurred in at least 3% of OTIPRIO patients and at an incidence greater than sham were nasopharyngitis (5% vs 4%). irritability (5% vs 3%). and rhinorrhea (3% vs 2%). The safety and effectiveness of OTIPRIO in infants below 6 months of age have not been established.

Robert S. Bridge, MD

Robert S. Bridge, MD is a Scottsdale resident and Chief of Otolaryngology at HonorHealth in Phoenix. He has been in practice for nearly 30 years and has been a member of the American Academy of Otolaryngology since 1989. Dr. Bridge is also a consultant to Otonomy. Inc., makers of OTIPRIO.

References: (1.) Rooenfeld RM, Schwartz SR. Pynnonen MA. at al. Clinical practice guideline: tympanostomy tubas In children-executive summary. Otolaryngol Head Neck Surg. 2013:149(1);8-16 (2.) Data on file, Otonomy. Inc. (3.) Mair EA. Park AH. Don D. Koempel J. Bear M. LeBel C. Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tuba Placement: Two Randomized Clinical Trials, JAMA Otolsryngol Head Neck Surg. 2016:142(5);444-451,
Primary Endpoint-Day 15 Treatment Failura Ratas
(Intent-to-treat population includes all randomized patients)

                Tubes Alone   OTIPRIO + Tubes

Study 1 N=268   45% (39/87)   25% (44/179)
Study 2 N=266   45% (40/88)   21% (J8/178)

Note: Table made from bar graph.
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Article Details
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Title Annotation:SPONSORED CONTENT
Author:Bridge, Robert S.
Publication:Ear, Nose and Throat Journal
Article Type:Case study
Geographic Code:1USA
Date:Oct 1, 2017
Words:772
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