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 U.S. 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 CEO 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 randomized, prospective, double-blind, sham-controlled Phase 3 clinical trials with a combined total of 532 pediatric 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 pediatric 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.