Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)

Exclusion Criteria

• •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 Valsalva maneuver. Subjects who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately. Subjects with tympanostomy tubes are not allowed.
• •Acute or chronic otitis externa.
• •Chronic otitis media (refers to current episode 2 wks).
• •Seborrheic dermatitis involving the affected external ear canal or pinna.
• •Any otic, topical, or systemic antibiotic received within 14 days prior to study entry (topical or systemic antibiotics for acne will be allowed on a chronic basis for subjects who have been on a stable dose for at least 14 days prior to entry).
• •Any topical drying agent or over-the-counter therapy for otitis media received within 36 hrs prior to enrollment.
• •Known hypersensitivity to drug or similar compounds including any of the inactive ingredients.
• •Subjects receiving medication on a chronic basis for pain (including steroidal or non-steroidal anti-inflammatory drugs) who have not been on a stable dose for at least 1 month prior to entry into the study.
• •Clinically significant mental illness that may interfere with the conduct of the study (determined by Investigator).
• •Exposure to any investigational agent within 30 days prior to study entry.
• •Previous enrollment in this study.
• •Subject/caregiver has a condition the Investigator believes would interfere with the ability to provide consent or assent (age-appropriate) or comply with study instructions, or that might confound the interpretation of the study results, or put the subject at undue risk.
• •Subject has a glucose 6-phosphate dehydrogenase deficiency or is taking concomitant medications associated with methemoglobinemia (such as nitrates or nitrites; aniline dyes; or medications, including lidocaine, prilocaine, phenazopyridine hydrochloride \[Pyridium\], and others).
• •Subject shows clinical signs of anemia. The absolute amount of deoxygenated or abnormal hemoglobin (rather than its percentage) is required for cyanosis to be clinically evident. Subjects with moderate-to-severe anemia may not appear cyanotic, even with elevated percentages of deoxygenated or abnormal hemoglobins.
• •Subject has congenital (i.e., hereditary) methemoglobinemia.
• •Subject has a recent history of acute gastroenteritis within 14 days prior to study entry.
• •Subject exhibits clinical signs of methemoglobinemia, such as unexplained bluish coloring of skin, fatigue, shortness of breath, failure to thrive, and headache.
• •Subjects 5 to \<19 yrs old who are unable to satisfactorily complete FPS-R screening test.