Otonomy, Inc. has completed enrollment in a phase 2 clinical trial evaluating AuriPro, a sustained-exposure formulation of the antibiotic ciprofloxacin, for the treatment of paediatric patients with acute otitis media with tympanostomy tubes (AOMT).
"We are very encouraged by the initial results of this trial which support the feasibility of administering AuriPro to fully alert children in a physician's office setting," said David A. Weber, Ph.D., president and CEO of Otonomy. "The rapid enrollment also demonstrates physician and caregiver interest in a product that can potentially provide a full course of antibiotic treatment in one ENT-administered dose."
The one-month, prospective, multicenter, open-label phase 2 clinical trial enrolled a total of 39 paediatric patients in the United States. The trial is designed to characterize safety, procedural factors and clinical effect of AuriPro administered in subjects with AOMT.
AuriPro is a sustained-exposure formulation of the antibiotic ciprofloxacin in development for the treatment of middle ear effusion in paediatric patients undergoing tympanostomy tube placement (TTP) surgery. AuriPro has been formulated to provide sustained-exposure of ciprofloxacin so that a single administration provides a full course of treatment. There are approximately one million TTP surgeries performed each year in the United States, and antibiotic ear drops are used in nearly all cases. Despite their routine use, no antibiotic ear drop has received FDA approval for this indication. Moreover, current ear drop products require multi-dose, multi-day regimens for efficacy. Full compliance with these regimens can be challenging, and missed antibiotic doses can compromise efficacy and increase the potential for bacterial resistance.
Otonomy filed a New Drug Application (NDA) for AuriPro for the treatment of middle ear effusion in paediatric patients undergoing TTP surgery to the FDA as of February 25, 2015. If approved within the standard review period, Otonomy anticipates a commercial launch for AuriPro in the United States in the first quarter of 2016.
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear.