Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society ...(eks) or remained on oral olanzapine at t...),Health

At the three higher doses, olanzapine LAI showed maintenance of treatment effect for schizophrenia for up to 24 weeks. Patients remained free of symptom exacerbation (relapse), as assessed by the Brief Psychiatric Rating Scale (BPRS), at a rate of 95 percent with 300 mg/two weeks, 90 percent with 405 mg/four weeks, and 84 percent with 150 mg/two weeks of olanzapine LAI. Comparatively, 93 percent of patients receiving oral olanzapine remained free of symptom exacerbation during the study. The 405 mg/four weeks and the pooled two-week dosing regimens showed non-inferiority when compared to oral olanzapine as well as to each other. All three higher olanzapine LAI doses had longer time to symptom exacerbation than the reference dose (all p<.01).

The safety profile for olanzapine LAI was consistent with that of oral olanzapine except for injection-related events. Incidence of weight gain of 7 percent or more from baseline was significantly higher for oral olanzapine (21.4 percent), olanzapine LAI 300 mg/two weeks (20.7 percent), olanzapine LAI 405 mg/four weeks (15.2 percent) and olanzapine LAI 150 mg/two weeks (16.4 percent) when compared with olanzapine LAI 45 mg/4 weeks (8.3 percent, all p less than or equal to .05). 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 Post-Injection Delirium/Sedation Syndrome (PDSS), which describes a range of signs and symptoms such as sedation, delirium, dizziness, confusion, disorientation, slurred speech and altered gait.

Across all olanzapine LAI clinical trials, PDSS events have been seen in 0.07 percent of injections and 1.4 percent of patients. As of 31 May, 2008, 29 events have been reported in 28 patients, all of whom have recovered fully. Given that awareness and recognition of t
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