March 12, 2007
Replidyne announced positive results from a phase II trial of Orapem for the treatment of acute otitis media in pediatrics. This randomized double-blind trial enrolled 300 pediatric subjects in Costa Rica and Israel. Treatment was administered orally, twice daily in one of four doses. Orapem was well tolerated across all dose levels. The trial met the primary endpoint, eradicating pathogens from the middle ear. In addition, an optimal dose for phase III trials was determined. Based on the results, Replidyne plans to meet with the FDA in order to discuss a phase III trial design.