Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media

Inclusion Criteria:

- Male or female patients ages 2 months to 12 years of age with a clinical diagnosis of
AOM, and with ear pain (current episode <2 weeks duration). Baseline pain entry
requires a minimum score of 4 on the FLACC or the FPS-R scale (depending on age)

- The patients must provide Institutional Review Board (IRB) approved written assent,
as appropriate, which must be accompanied by an IRB approved written informed consent
form (ICF) from the patient's legally acceptable representative (i.e., parent or
guardian), as applicable. In addition, all patients or their legally acceptable
representatives (i.e., parent or guardian) must sign a Health Insurance Portability
and Accountability Act (HIPAA) authorization, if applicable

- Patients must be normally active and otherwise judged to be in good health on the
basis of the medical history and a limited physical examination, as determined by the
Investigator.

- Females of child bearing potential must have a negative urine human chorionic
gonadotropin (hCG) pregnancy test at Visit 1

Exclusion Criteria:

- Patients with bilateral AOM, perforated tympanic membrane, history of a perforated
tympanic membrane in the last 6 months, or if a perforated tympanic membrane could
not be ruled out by speculum examination, impedance testing tympanometry, pneumatic
otoscopy, or a Valsalva maneuver

- Patients who are subsequently diagnosed with a perforated membrane during treatment
are to be discontinued immediately.

- Patients with indwelling tympanostomy tubes or draining otitis in the affected
ear(s), bullous lesions, erythema of the tympanic membrane without other evidence of
AOM, and patients with an anatomic defect of the ear or nasopharynx

- Complications of treated/untreated ear disease over the past 2 weeks

- Patients with comorbidity requiring antibiotic therapy, allergy to study medication,
immunologic deficiency, and major medical condition(s).

- Patients with methemoglobinemia or a history of methemoglobinemia, vertigo, inherited
enzyme deficiencies, impaired cardiac or respiratory functions, epilepsy, heart
diseases, hypersensitivity, pyrogenic infection at or near the skin, inflamed or
infected skin, dermatitis, shock, hepatic impairment, or myasthenia gravis

- Acute or chronic otitis externa

- Chronic otitis media (current episode ≥ 2 weeks)

- Patients who smoke are prohibited from participating in this study.

- Seborrheic dermatitis involving the affected external ear canal or pinna

- Any topical or systemic antibiotic received within the 14 days prior to study entry
(topical antibiotics for acne will be allowed)

- Any topical drying agent or over-the-counter (OTC) therapy for otitis media received
within 36 hours prior to enrollment

- Fever >102°F

- Known hypersensitivity to the study drug or similar compounds including any of the
inactive ingredients

- Patients receiving medication on a chronic basis for pain (including steroidal or
non-steroidal anti-inflammatory drugs)

- Use of ear drops or oral analgesics such as ibuprofen/acetaminophen within the 4
hours prior to study entry

- Use of sulfonamides, aminosalicylates, anti- cholinesterases, suxamethonium,
antiarrhythmics, monoamine oxidase inhibitors, or tricyclic antidepressants

- Clinically significant mental illness (as determined by the Investigator)

- Exposure to any investigational agent within the 30 days prior to study entry

- Previous enrollment in this study

- Pregnant or lactating

- The child has a condition that the Investigator believes would interfere with the
ability to provide assent (age appropriate) or comply with study instructions, or
that might confound the interpretation of the study results, or put the child at
undue risk