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Title: FDA Approves Aripiprazole for Paediatric Patients With Bipolar Disorder

"FDA Approves Aripiprazole for Paediatric Patients With Bipolar Disorder"

NEW YORK -- February 29, 2008 -- The US Food and Drug Administration (FDA) has approved aripiprazole (Abilify) for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features, in paediatric patients (aged 10 to 17 years). Aripiprazole has been approved for acute and maintenance treatment of this disorder in adults since September 2004 and March 2005, respectively. "The availability of an additional treatment option that can help guide decisions in managing bipolar I disorder in children and adolescents is welcome news," said Christoph Correll, MD, Medical Director of the Recognition and Prevention Program at Zucker Hillside Hospital and Assistant Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine, Glen Oaks, New York. The FDA approval is based on results from a 4-week, multicentre, randomised, double-blind, placebo-controlled study in patients (N = 296) aged 10 to 17 years with bipolar I disorder. Patients with manic or mixed episodes, with or without psychotic features, were included. The primary efficacy endpoint was mean change from baseline to week 4 on the Young-Mania Rating Scale (Y-MRS) total score. After a screening period of up to 4 weeks, paediatric patients who scored >= 20 on the Y-MRS were randomly assigned to receive 1 of 2 fixed doses of aripiprazole (10 mg/d [n = 98] or 30 mg/d [n = 99]) or placebo (n = 99). Aripiprazole was initiated at a starting dose of 2 mg/d and titrated to the target dose of 10 or 30 mg/d. Y-MRS total scores range from 0 (no manic symptoms) to 60 (severe mania).(1,2) Both doses of aripiprazole demonstrated statistically significant improvement in symptoms when compared with placebo ([P < .0001) as measured by the mean change from baseline to endpoint (week 4) on the Y-MRS total score.

Approximately 80% of patients completed the 4-week study (aripiprazole 10 mg: 86%; aripiprazole 30 mg: 78%; placebo: 77%). At week 4, the rate of discontinuation due to adverse reactions was low (aripiprazole: 7%; placebo: 2%). The most commonly observed adverse reactions associated with aripiprazole were somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness. Four common adverse reactions had a possible dose-response relationship at week 4: extrapyramidal disorder (aripiprazole 10 mg: 12.2%; aripiprazole 30 mg: 27.3%; placebo: 3.1%), somnolence (aripiprazole 10 mg: 19.4%; aripiprazole 30 mg: 26.3%; placebo: 3.1%), akathisia (aripiprazole 10 mg: 8.2%; aripiprazole 30 mg: 11.1%; placebo: 2.1%), and salivary hypersecretion (aripiprazole 10 mg: 3.1%; aripiprazole 30 mg: 8.1%; placebo: 0%). Children and adolescents might be more sensitive than adults in developing antipsychotic-related adverse events.(3)

In the study, weight gain >= 7% change from baseline was seen in 3.2% of the aripiprazole 10 mg group versus 9.4% for aripiprazole 30 mg and 3.3% for placebo. The mean change from baseline to week 4 in body weight was 0.6 kg for aripiprazole 10 mg, 0.9 kg for aripiprazole 30 mg, and 0.5 kg for placebo.

In this study, aripiprazole demonstrated no clinically important differences on prolactin and the following metabolic parameters: triglyceride, HDL-C, LDL-C, and total cholesterol. All treatment groups showed a reduction in mean serum prolactin levels at last visit relative to baseline.

References
1. Young RC et al. Br J Psychiatry. 1978;133:429--435.

2. Rush AJ et al. Handbook of Psychiatric Measures. Washington, DC: American Psychiatric Association; 2000.

3. Kumra S et al. Schizophr Bull. 2008;34:60-71. Epub 2007 Oct 8.

SOURCE: Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company

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