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

overall rate of treatment discontinuation or mean change in PANSS score, two standard measures of treatment effectiveness in schizophrenia, among patients who were switched directly to olanzapine LAI and those who were tapered. Additionally, no significant differences were seen in the overall number of treatment-emergent adverse events, changes in laboratory measures or mean weight change.

Regulatory reviews for olanzapine LAI are ongoing in the United States and other countries. Olanzapine LAI is approved in the European Union under the brand name Zypadhera(R) for maintenance treatment of adults with schizophrenia who have been sufficiently stabilized during acute treatment with oral olanzapine.

Additional olanzapine LAI data presented today at the annual meeting of the American Psychiatric Association include: an analysis of the role of oral supplementation in the administration of long-acting antipsychotics; an analysis of PDSS; and a meta-analysis of olanzapine LAI, olanzapine and haloperidol data. Additionally, a cost-effectiveness simulation analysis comparing olanzapine LAI to risperidone LAI, haloperidol LAI and oral olanzapine was presented.

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The primary objective of this ongoing open-label study is to examine the long-term safety and tolerability of olanzapine LAI. Current results are from an interim analysis, with maximum treatment duration of 190 weeks. Adult patients with schizophrenia or schizoaffective disorder (N=931) were enrolled following one of three randomized, controlled studies of olanzapine LAI, in which patients had been randomly assigned to oral olanzapine, olanzapine LAI or placebo. During the open-label extension, all patients received flexibly-dosed olanzapine LAI at injection intervals of approximately two to four weeks.

At time of analysis, rate of study discontinuation was 46.3 percent. Discontinuation rate at 18 months was 34.3 perce
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