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

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.

What this study is about