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US FDA approves ABILIFY for adolescent patients with schizophrenia
Date:11/6/2007

The findings are from a six-week, double-blind, randomized, placebo-controlled, multi-center study that evaluated the efficacy and safety of ABILIFY in pediatric patients, 13-17 years old, with a primary diagnosis of schizophrenia. (1) The study, sponsored by Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, N.J.), was conducted at 101 centers in 13 countries and enrolled 302 ethnically diverse pediatric patients. All patients were experiencing an acute episode of schizophrenia and required hospitalization at the time of enrollment. (1) After a minimum three-day wash-out period without any antipsychotic treatment, pediatric patients were randomly assigned to receive one of two fixed doses of ABILIFY [10 mg/day (n=100) or 30 mg/day (n=102)] or placebo (n=100). (1) ABILIFY was started at 2 mg/day and titrated to the target dose. (1)

The primary efficacy endpoint was the mean change from baseline to endpoint (Week 6) in a standard measure called the PANSS Total Score, (1) which can range from 30 (no symptoms) to 210 points (most severe symptoms). (2) Safety evaluations included incidence of adverse events, discontinuation rate due to adverse events and laboratory measures. (1)

Approximately 85 percent of patients completed the six-week study (84 percent of ABILIFY 10 mg, 82 percent of ABILIFY 30 mg and 90 percent of placebo-treated patients). (1) Both doses of ABILIFY demonstrated significant improvement when compared to placebo in mean change from baseline to endpoint (Week 6) in PANSS Total Score. (1)

In this study of pediatric patients with schizophrenia, common adverse events (greater than or equal to 5 percent and at least twice the rate of placebo) associated with ABILIFY were extrapyramidal disorder, somnolence and tremor. These common adverse reactions appeared to have a possible dose response relationship: extrapyramidal disorder (ABILIFY 10 m
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Contact: Debra Kaufmann
debra.kaufmann@otsuka.com
240-683-3568
Otsuka America Pharmaceutical, Inc.
Source:Eurekalert

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