The US Food and Drug Administration (FDA) has accepted the filing of Otonomy's New Drug Application (NDA) for AuriPro for the treatment of middle ear effusion in paediatric patients undergoing tympanostomy tube placement (TTP) surgery.
The acceptance of the NDA indicates the application is sufficiently complete to permit a substantive review by the FDA.
"The FDA's acceptance of our NDA filing brings us one step closer to the potential approval and US commercial launch of AuriPro, which is on track to be the first product marketed for the treatment of middle ear effusion during TTP surgery," said Dave Weber, Ph.D., president and chief executive officer of Otonomy.
"In addition, based on pre-NDA communications, we do not believe that the FDA will convene an advisory committee meeting for AuriPro prior to its approval."
The NDA submission is supported by data from two identical randomised, prospective, double-blind, sham-controlled phase 3 clinical trials with a combined total of 532 paediatric patients. In both trials, AuriPro achieved the primary efficacy endpoint of reducing the incidence of treatment failures with statistical significance (p<0.001) and was well tolerated.
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.
The FDA is currently reviewing Otonomy's New Drug Application (NDA) for AuriPro for the treatment of middle ear effusion in paediatric patients undergoing TTP surgery. If approved within the standard review period, Otonomy anticipates a commercial launch for AuriPro in the United States in the first quarter of 2016.