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| |  FDA Approves Aripiprazole to Treat Irritability Associated With Autistic Disorder NEW YORK -- November 20, 2009 -- The US Food and Drug Administration has approved aripiprazole (Abilify) for the treatment of irritability associated with autistic disorder in paediatric patients aged 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. The efficacy of aripiprazole for the maintenance treatment of irritability associated with autistic disorder has not been evaluated. While there is no body of evidence available to answer the questions of how long the patient treated with aripiprazole should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment. The approval of the new indication was based on 2 studies: Study CN138-178 (a flexible-dose study involving 98 patients) and study CN138-179 (a fixed-dose study involving 218 patients). Both studies enrolled patients aged 6 to 17 years (75% were <13 years). In both studies, the primary efficacy endpoint was the mean change from baseline to week 8 in the Irritability subscale of the caregiver-rated Aberrant Behaviour Checklist (ABC-I) score. Patients in CN138-178 were randomised in a 1:1 ratio to receive either aripiprazole 2 mg/day to 15 mg/day or placebo. The mean daily dose at the end of the 8-week treatment was 8.6 mg/day with the majority of patients taking either 5 or 10 mg/day. Aripiprazole demonstrated significantly greater improvement compared with placebo on the primary study endpoint, the adjusted mean change from baseline to week 8 on the ABC-I Subscale score (P < .001). Aripiprazole also demonstrated a statistically significant greater improvement compared with placebo on the adjusted mean Clinical Global Impression (CGI) scores at week 8 (P < .001). Patients in the fixed-dose study (CN138-179) were randomized in a 1:1:1:1 ratio to receive 1 of 3 doses of aripiprazole (5 mg/day, 10 mg/day or 15 mg/day) or placebo. Patients receiving aripiprazole initiated treatment at a dose of 2 mg/day for 1 week. The dose of aripiprazole was increased to 5 mg/day for 1 week, and then increased by 5 mg/day at weekly intervals until the assigned dose was achieved. Each dose of aripiprazole demonstrated significantly greater improvement compared with placebo on the primary study endpoint: the adjusted mean change from baseline to week 8 on the ABC-I Subscale score (5 mg, P < .05; 10 mg; P < .01; 15 mg, P = .001, placebo). Differences between dose groups were not evaluated. The weight gain observed at week 8 in a pooled analysis of the 2 studies was 1.6 kg for aripiprazole versus 0.4 kg for placebo. Clinically significant weight gain (>= 7% change from baseline) was seen in 26% of aripiprazole-treated patients and 7% of placebo-treated patients. There were no clinically significant differences in lipids compared with placebo. Commonly observed adverse events across both studies were sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. The rate of discontinuation due to adverse reactions was 10% for aripiprazole and 8% for placebo. The most common reasons for discontinuation were sedation, drooling, tremor, vomiting, and extrapyramidal disorder. SOURCE: Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb
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