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

nt. The most common reasons for discontinuation were patient's decision (23.4 percent), followed by adverse events (6.7 percent). Adverse events in greater than or equal to five percent of patients were increased weight, insomnia, anxiety, somnolence, headache and inflammation of the nasal passages and upper pharynx (nasopharyngitis).

Safety findings were consistent with those observed with oral olanzapine, with the exception of injection related events, including PDSS. There were 26 occurrences of PDSS. All of these patients recovered within 72 hours. Mean weight change was +1.88 kg, with 32.1 percent of patients experiencing greater than or equal to seven percent weight gain. Percentages of patients who increased from normal to high on fasting glucose, random total cholesterol, or random triglycerides were 5.5 percent, 5.2 percent and 14.3 percent, respectively. Mean Clinical Global Impressions-Severity scores remained stable throughout (2.9 at baseline to 2.8 at endpoint).

About HGLQ

The primary objective of this two-year, ongoing open-label study is to compare the treatment effectiveness of the oral and long-acting formulations of olanzapine in adult outpatients with schizophrenia considered at risk for relapse. The eight-month interim analysis of this study was conducted in order to compare the safety and effectiveness of direct switch versus taper of previous antipsychotic medication when changing to olanzapine LAI. Analyses were based on eight-month data from only those patients treated with olanzapine LAI (N=264). Patients received olanzapine LAI every four weeks with a starting dose of 405 mg and flexible dosing thereafter. Investigators, at their discretion, could either directly switch patients or taper their previous antipsychotic medication during the first two weeks of treatment.

At the time of study entry, patients were either receiving typical antipsychotics (N=63), atypical a
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