LILLY ZYPREXA RELAPSE PREVENTION CLAIM BEING DISCUSSED WITH FDA FOR PHASE IV; OLANZAPINE PARKINSON-LIKE SIDE EFFECTS ARE SIMILAR TO PLACEBO EXPERIENCE
Executive Summary
Lilly is pursuing an explicit maintenance claim for the anti-psychotic Zyprexa in Phase IV discussions with FDA following the approval of the drug. The company and FDA will confer on the definition and endpoints that would be required to demonstrate relapse prevention in schizophrenic populations that could lead to a maintenance indication for Zyprexa. There is a lack of consensus in the U.S. scientific community on how to define relapse prevention, Lilly says.