US-based biopharmaceutical firm Otonomy has completed enrolment in a Phase II clinical trial of AuriPro, a sustained-exposure formulation of the antibiotic ciprofloxacin, to treat paediatric patients with acute otitis media with tympanostomy tubes (AOMT).
AuriPro is being developed to treat middle ear effusion in paediatric patients undergoing tympanostomy tube placement (TTP) surgery.
The drug has been formulated to provide sustained-exposure of ciprofloxacin so that a single administration provides a full course of treatment.
A total of 39 paediatric patients in the US were enrolled in the one-month, prospective, multi-centre, open-label Phase II trial, which is designed to characterise safety, procedural factors and clinical effect of AuriPro administered in subjects with AOMT.
Otonomy president and CEO David Weber said: "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.
"The rapid enrolment also demonstrates physician and caregiver interest in a product that can potentially provide a full course of antibiotic treatment in one ENT-administered dose."
Annually, there are about one million TTP surgeries performed in the US, and antibiotic ear drops are used in nearly all cases an despite their routine use, no antibiotic ear drop has received FDA approval for this indication.
In addition, current ear drop products require multi-dose, multi-day regimens for efficacy.
In February this year, the company had filed a new drug application (NDA) to the US Food and Drug Administration (FDA) for AuriPro to treat middle ear effusion in paediatric patients undergoing TTP surgery
The company said that if approved within the standard review period, AuriPro is expected to be launched in the US in the first quarter of 2016.