BROOKLYN, N.Y. - A new otic suspension combining an anti-inflammatory and an anti-infective was recently approved by the Food and Drug Administration (FDA) for the treatment of acute otitis externa (AOE).
Cipro HC Otic suspension (ciprofloxacin hydrochloride/hydrocortisone otic suspension, Bayer) is indicated for the treatment of AOE in adults and children older than 1 year. Cipro HC Otic demonstrated clinical efficacy against Pseudomonas aeruginosa, Staphylococcus aureus and Proteus mirabilis, the most common pathogens known to cause AOE.
The FDA based its decision on the results of a recent prospective multicenter trial with Cipro HC Otic suspension administered for one week. The study showed significant reduction in time to end-of-ear pain in patients at least 2 years of age with a primary diagnosis of acute diffuse bacterial otitis externa, compared with patients treated with ciprofloxacin solution alone.
The study compared the efficacy and safety of ciprofloxacin otic drops - with or without hydrocortisone - to polymyxin B-neomycin-hydrocortisone otic suspension for the treatment of AOE. The study was also designed to determine the time-to-end of ear pain for each treatment.
The study enrolled 842 patients, and 728 participants met the inclusion criteria. Those patients randomly received ciprofloxacin otic solution (cip solution), ciprofloxacin hydrocortisone otic suspension (cip/HC) or polymyxin B-neomycin-hydrocortisone otic suspension (PNH) for one week.
Cip solution (0.2%) and cip/HC suspension (0.2%/1%) were each given as three drops twice daily and PNH was administered as nine to 12 drops three times daily.
Drug-related adverse events were reported in 6% of cip solution patients; 5% of those who received cip/HC suspension; and 5% of PNH recipients. The most commonly reported drug-related adverse events included headache, ear pain and pruritis.
Inclusion criteria for the study included children age 2 years or older, primary diagnosis of acute diffuse bacterial otitis externa for three or more weeks, and clinical signs and symptoms of external otitis within two days of study entry including: edema of the external auditory canal, tenderness with movement of the pinna and otalgia.
The study enrolled children and adults, and the average age of study participants was 24 years, said Steven Jungerwirth, MD, director of anti-infective drugs research at Bayer.
Clinical success was statistically equivalent for all treatment arms: cip solution (93%); cip/HC suspension (90%); and PNH (88%). Clinical response was similar among the treatment groups regardless of age, but patients older than 16 years had fewer episodes of complete resolution.
Patients were excluded from the study if diagnosed with acute otitis media, invasive malignant chronic otitis externa, dermatitis in the area of the affected ear or recent (less than 30 days) diagnosis and treatment of otitis externa.
Other exclusion data included: perforated tympanic membrane, known fungal infection of the ear, furuncles, mastoiditis, stenosis, exostosis, ear tumors, significant underlying disease, allergy to carboxyquinolones or PNH components, pregnancy/nursing, administration of another investigational drug within 30 days of study and previous enrollment in this study.
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