BMS schizophrenia drug approved for use in adolescents
The US Food and Drug Administration (FDA) has approved the supplemental New Drug Application for Bristol-Myers Squibb's atypical antipsychotic Abilify (aripiprazole) for the treatment of schizophrenia in adolescents aged 13-17 years.
The US Food and Drug Administration (FDA) has approved the supplemental New Drug Application for Bristol-Myers Squibb's atypical antipsychotic Abilify (aripiprazole) for the treatment of schizophrenia in adolescents aged 13-17 years.
Abilify is a dopamine partial agonist indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults. Over 12.5 million prescriptions have been written for it in the US through June 2007.
In adolescents, Abilify treats positive and negative symptoms of schizophrenia.
Otsuka and Bristol-Myers Squibb are collaborative partners in the development and commercialisation of the drug in the US and major European countries. This latest development follows the results of an Otsuka-sponsored study into its efficacy, safety and tolerability in peadiatric patients ages 13-17 with schizophrenia.
"Until now, FDA-approved treatment options for adolescent patients with schizophrenia were limited," said Robert Findling, director of Child and Adolescent Psychiatry, University Hospitals Case Medical Center, Cleveland, Ohio. "The approval of this new indication for Abilify provides an additional effective treatment option for these patients."