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Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months
Date:9/2/2008

nce of weight gain of 7 percent or more from baseline was significantly higher for patients treated with oral olanzapine (21.4 percent), olanzapine LAI 150 mg every two weeks (16.4 percent), olanzapine LAI 300 mg every two weeks (20.7 percent) and olanzapine LAI 405 mg every four weeks (15.2 percent) when compared with patients treated with olanzapine LAI 45 mg every 4 weeks (8.3 percent, all p less than or equal to .05). The incidence of all injection site reactions, including injection pain, was 2.8 percent. Adverse events reported in 5 percent or more of patients were insomnia, weight increase, anxiety, nasopharyngitis, somnolence and headache. In HGKA, two patients experienced and recovered fully from Olanzapine LAI Post-Injection Syndrome, which includes a range of symptoms of sedation (ranging from mild in severity to unconsciousness) and/or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment). Other symptoms include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension and convulsion.

Earlier this year, data pertaining to the study's primary relapse endpoint was disclosed at the Schizophrenia International Research Society (SIRS) Conference. These data showed that patients treated with all three higher doses of olanzapine LAI had longer time to symptom exacerbation than patients who received the reference dose and that the four-week 405 mg and the pooled two-week dosing regimens showed non inferiority when compared to oral olanzapine and to each other.

About Olanzapine LAI Post-Injection Syndrome Analysis

As with all medications, there are risks associated with the use of long- acting injections. Across all olanzapine LAI clinical trials, olanzapine LAI showed a similar safety profile as the oral formulation except for injection- related events, including Olanzapine LAI Post-Injection Syndrome.

The purpose of this analysis was to review the Olanzapine
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SOURCE Eli Lilly and Company
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