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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Adolescent Patients With Schizophrenia
Date:11/6/2007

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 mg: 13 percent; ABILIFY 30 mg: 21.6 percent; placebo: 5 percent), somnolence (ABILIFY 10 mg: 11 percent; ABILIFY 30 mg: 21.6 percent; placebo: 6 percent) and tremor (ABILIFY 10 mg: 2 percent; ABILIFY 30 mg: 11.8 percent; placebo: 2 percent). The discontinuation rate due to an adverse event was 5 percent for ABILIFY and 2 percent for placebo.

In this six-week study, weight gain greater than or equal to 7 percent increase from baseline was seen in 5 percent of pediatric patients treated with ABILIFY and 1 percent of placebo-treated patients. The mean change from baseline in weight was 0.13 kilograms (kg) for ABILIFY and -0.83 kg for placebo.

About ABILIFY

The first and only available dopamine partial agonist, ABILIFY is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults. ABILIFY is also indicated for the treatment of schizophrenia in adults and adolescents (13-17 years old). ABILIFY Injection is indicated for the treatment of adults with agitation associated with schizophrenia or Bipolar I Disorder, manic or mixed.

Initially approved in November 2002, over 12.5 million prescriptions have been written for ABILIFY in the U.S.(3) through June 2007.

ABILIFY is available by prescription only. ABILIFY tablets should be taken once daily with or without food and are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths. ABILIFY DISCMELT(TM) Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. In addition, ABILIFY is available in a 1 mg/mL nonrefrigerated oral solution and as a single-dose ready-to-use solution for intramuscula
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SOURCE Otsuka Pharmaceutical Co., Ltd.
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