Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Otonomy has completed patient enrollment in a Phase II clinical trial evaluating AuriPro, a sustained-exposure formulation of the antibiotic ciprofloxacin, to treat acute otitis media with tympanostomy tubes (AOMT).
Subscribe to our email newsletter
The one-month, prospective, multicentre, open-label Phase II trial enrolled a total of 39 pediatric patients in the US and is designed to characterize safety, procedural factors and clinical effect of AuriPro administered in these subjects.
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 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."
AuriPro is being developed to treat middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery and it has been formulated to provide sustained-exposure of ciprofloxacin so that a single administration provides a full course of treatment.
Earlier this February, a new drug application (NDA) has been submitted to the US Food and Drug Administration (FDA) for AuriPro for the treatment of middle ear effusion in pediatric patients undergoing TTP surgery.
According to the company, if approved within the standard review period, AuriPro is expected to be launched in the US in the first quarter of 2016.