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news.Replidyne has said its drug faropenem medoxomil for pediatric patients with acute otitis media, a common infection of the middle ear, met the primary goal of a phase II trial.
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Initial analyses of the study results show that it met its primary objective to show that faropenem was effective in eradicating pathogens from the middle ear and to permit the dose selection for phase III trials in acute otitis media (AOM).
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.
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 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,” said Kenneth Collins, Replidyne's president and CEO.
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.