Replidyne is reporting positive results from a Phase II trial of faropenem medoxomil in pediatric patients with a common infection of the middle ear. The infection--acute otitis media--is responsible for about 30 million pediatric doctor's visits each year in the U.S. Just last months Forest Laboratories backed out of a deal with Replidyne for the development of faropenem medoxomil after the FDA rejected the therapy for several adult indications. "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," said Kenneth J. Collins, Replidyne's President and CEO. Replidyne was a 2006 Fierce 15 winner.
- see Replidyne's release for more