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Olanzapine Long-Acting Injection (LAI) Efficacy and Safety Data Presented at American Psychiatric Association Annual Meeting
Date:5/18/2009

Three-year data show olanzapine LAI safety findings consistent with oral olanzapine except for injection-related events

INDIANAPOLIS, May 18 /PRNewswire-FirstCall/ -- Eli Lilly and Company presented today data on the short- and long-term efficacy and safety of olanzapine long-acting injection (LAI) in the treatment of adults with schizophrenia or schizoaffective disorder. Olanzapine LAI is an investigational formulation that combines the atypical antipsychotic Zyprexa(R) (olanzapine) with pamoic acid, allowing for the sustained delivery of olanzapine for up to four weeks.

Results from a 190-week interim analysis of a six-year, ongoing, open-label study (HGKB), showed that adults with schizophrenia or schizoaffective disorder treated with olanzapine LAI had a discontinuation rate of 46.3 percent. The most common reason for discontinuation was the patient's decision (23.4 percent) followed by adverse events (6.7 percent). Safety findings were consistent with those observed with oral olanzapine, with the exception of injection-related events, including post-injection delirium/sedation syndrome (PDSS), which is characterized by sedation- and/or delirium-related symptoms following injection.

"Discontinuation of medication plays a major role in schizophrenia relapse," said Holland Detke, Ph.D., clinical research scientist at Lilly. "Four out of five patients who stop taking their medications after a first episode of schizophrenia will have a relapse. The more relapses a patient has, the more difficult it becomes for them to recover from each successive relapse."(1)

Also presented today were eight-month interim results from a two-year, ongoing, open label study (HGLQ) that showed patients with schizophrenia could be switched to olanzapine LAI from a previous antipsychotic, either using a direct switch or while tapering their previous antipsychotic medication. No significant difference was found in
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