REPLIDYNE ANNOUNCES RESULTS FROM EAR-INFECTION STUDY

Replidyne has completed its Phase II clinical trial using faropenem medoxomil in pediatric patients with acute otitis media, a common infection of the middle ear. 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 the findings permit the dose selection for Phase III trials.

The study of more than 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 on tolerability.

The trial included a double-tap design where middle ear fluid was obtained both prior to and during treatment and then submitted for culture. These cultures provide microbiologic documentation of faropenem's effectiveness in eradicating bacteria from the middle ear fluid.

"The results give us confidence that we will be able to select an appropriate dose for Phase III studies," Kenneth Collins, Replidyne's president and CEO, said. "We plan to meet with the FDA in the second quarter to share these data and discuss Phase III trial design."

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, according to the company.