Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media

Inclusion Criteria: * Subjects 2 mo. to \< 19 yrs of age, with signs and symptoms of AOM, with moderate to severe pain (current episode 2 wks duration). Moderate to severe pain is defined as a score of 5 (on a scale of 0 - 10) on the FAECC pain scale as evaluated by a trained clinical staff or 6 (on a scale of 0 - 10) on the FPS-R as evaluated by the subject. Moderate to severe pain criteria must be met at eligibility and the pre-dose pain assessment. * Males or non-pregnant, non-lactating females. * The subject's caregiver must have read and signed the written informed consent (including assent from subjects 18 yrs as applicable according to Investigational review board (IRB) guidelines) prior to study participation. * Subjects 18 yrs old must have read and signed the written informed consent prior to study participation. * Normally active and otherwise judged to be in good health on the basis of medical history and limited physical examination. * Females of childbearing potential must have a urine pregnancy test at the randomization visit with negative results returned prior to randomization. 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 imme…