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Phase 2 Trial Results of Faropenem Demonstrates Efficacy in Treating Otitis Media
The study of over 300 pediatric patients examined four different doses of faropenem, administered twice daily as an oral suspension, and demonstrated a dose response in bacteriological eradication. All doses examined were well tolerated and there was no clear dose effect to tolerability. The trial included a double tap design where middle ear fluid is obtained both prior to and during treatment then submitted for culture. These cultures provide microbiologic documentation of faropenem's effectiveness in eradicating bacteria from the middle ear fluid.
"We are pleased with the positive results and rich bacteriological and clinical data generated from this study, and look forward to presenting these data in more detail at an upcoming scientific conference," said Kenneth J. Collins, Replidyne's President and CEO. "The results give us confidence that we will be able to select an appropriate dose for Phase III studies. We plan to meet with the FDA in the second quarter to share these data and discuss Phase III trial design for faropenem in pediatric AOM."
Faropenem is a member of the penem subclass within the beta-lactam class of antibiotics. Beta-lactams are generally characterized by their favorable safety and tolerability profiles, as well as their broad spectrum of activity, and as a result are often used as first line therapy in many respiratory and skin infections in adult and pediatric patients.
About Acute Otitis Media
Acute otitis media (AOM) is the most frequent pediatric bacterial infection that results in the prescription of an antibiotic and accounts for 30 million office visits in the US annually. Oral antibiotics are the most widely prescribed medicines to treat AOM in children and fall into two primary classes, macrolides and beta-lactams. According to IMS data, beta-lactams represent 88% of all pediatric antibiotic prescriptions for this illness.