Recently, the medication Abilify (aripiprazole) was approved by the FDA for the treatment of schizophrenia in the adolescent population aged 13 - 17. This is a significant development in the treatment of schizophrenia, and I thought it would be interesting to explain how this medication received this new indication after being on the market for several years.
On November 6th, 2007 it was announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for the medication Abilify (aripiprazole) for the treatment of schizophrenia in people ages 13 - 17. Over 12.5 million prescriptions have been written for this medication since it was initially approved by the FDA for the treatment of schizophrenia in adults in 2002. In addition to treatment of schizophrenia in adults, the medication has also been approved by the FDA for treatment of mixed or manic episodes in bipolar I disorder in adults and the injectable form of the medication has been used for the treatment of agitation in adults due to a mixed or manic episode of Bipolar I disorder or schizophrenia.
This new indication for adolescents age 13- 17 was based in part on the results from a randomized, placebo-controlled, double-blinded study of six weeks duration. This study was sponsored by Otsuka Pharmaceutical Company, Ltd, and its US subsidiary. There were 302 pediatric patients age 13 - 17 from 101 centers in 13 countries involved in the study. These patients had been experiencing an acute exacerbation of schizophrenia which required hospitalization when they entered the study. After a washout period during which no antipsychotic treatment was administered, the patients were randomly assigned to receive either aripiprazole or a placebo for six weeks. 85% of these patients were able to complete the study, and of these, patients taking aripiprazole had improvement in their symptoms. This improvement was measured by scores on the PANSS Total Score scale (The positive and negative syndrome scale for schizophrenia). This scale showed an improvement in score in patients taking aripiprazole compared to those patients taking a placebo. This scale has been used in many other studies of the treatment of schizophrenia, and is a way of tracking improvement or worsening of symptoms of the illness during studies.
The results of this research also showed that patients taking aripiprazole did have more side effects than those taking placebo. The most commonly reported side effects in patients taking aripiprazole compared to placebo in this study were extrapyramidal tremor, somnolence, and tremor. In previous blogs I described some of the differences between certain movement disorders associated with the treatment of schizophrenia.
Hopefully this will give you some idea of how medications for the treatment of schizophrenia get approved and are used in special populations like adolescence. Please keep in mind that this information is purely that, information, and in no way should substitute clinical judgment. If you have any questions about aripiprazole or the diagnosis of schizophrenia, consult your primary care provider or your psychiatrist. A future blog can go into greater detail as to how the FDA approves medication, but as always I am interested in hearing your comments and questions.