Discovered by Otsuka and jointly developed and commercialized by Otsuka and Bristol-Myers, ABILIFY is the first and only available dopamine partial agonist and is indicated for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and pediatric patients (ages 10-17).
It is also indicated for the maintenance treatment of Schizophrenia in adults and adolescents (ages 13-17), and as an adjunctive treatment to an antidepressant in adults with Major Depressive Disorder who have an inadequate response to antidepressant therapy.
In a randomized, double-blind, placebo-controlled study, patients were initiated on open-label lithium (0.6 mEq/L to 1.0 mEq/L) or valproate (50 µg/mL to 125 µg/mL) at therapeutic serum levels, and remained on stable doses for two weeks.
The number of observed manic episodes in the ABILIFY (aripiprazole) group (7) was fewer than that in the placebo group (19), while the number of depressive episodes in the ABILIFY group (14) was similar to that in the placebo group (18).
Otsuka Pharmaceutical Development and Commercialization president and CEO William Carson said by updating the label to include maintenance treatment with ABILIFY as an add-on to lithium or valproate for patients with Bipolar I Disorder, they are helping to provide more options to physicians.
Bristol-Myers Squibb vice president of US Medical John Tsai said because Bipolar Disorder is a lifelong and recurrent illness, this labeling update provides physicians with the option to prescribe ABILIFY as an add-on to either lithium or valproate as a long-term treatment to help manage symptoms of Bipolar I Disorder.