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Aripiprazole Receives Expanded Paediatric Indications for Bipolar I Disorder and Schizophrenia
TOKYO and PRINCETON, NJ -- May 9, 2008 -- Aripiprazole (Abilify) is now indicated for maintenance treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in paediatric patients aged 10 to 17 years and for maintenance treatment of schizophrenia in adolescents aged 13 to 17 years. In addition, aripiprazole also is approved as adjunctive therapy to either lithium or valproate 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 was recently approved 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 in February 2008 and for the acute treatment of schizophrenia in adolescents aged 13 to 17 years in October 2007. The US Food and Drug Administration first approved aripiprazole for the treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults in September 2004 and for the treatment of schizophrenia in adults in November 2002.
The safety and effectiveness of aripiprazole in paediatric patients with bipolar mania were established in a 4-week, placebo-controlled clinical trial in 197 paediatric patients (aged 10-17 years). The safety and effectiveness of aripiprazole in adolescents with schizophrenia were established in a 6-week, placebo-controlled clinical trial in 202 paediatric patients (aged 13-17 years). Although maintenance efficacy in these patient populations has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adults and paediatric patients.
There is no body of evidence available to answer the question of how long the adolescent patient treated with aripiprazole should be maintained. It is generally recommended that responding patients be continued beyond the acute response but at the lowest dose needed to maintain remission. Periodic reassessment should be conducted to determine the need for maintenance treatment.
The efficacy of adjunctive aripiprazole with concomitant lithium or valproate in the treatment of manic or mixed episodes in paediatric patients has not been systematically evaluated. However, such efficacy and lack of pharmacokinetic interaction between aripiprazole and lithium or valproate can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and paediatric patients.
SOURCE: Bristol-Myers Squibb Company
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