Abilify gains pediatric indication

The FDA has approved Abilify (aripiprazole, from Otsuka and Bristol-Myers Squibb) for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in patients 10-17 years of age. This approval is based on a 4-week study involving 296 children aged 10 to 17 years which showed significant improvement in bipolar I disorder symptoms in the Abilify-treated group when compared to placebo.

Abilify, a dopamine partial agonist, is already indicated for the acute and maintenance treatment of manic or mixed episodes in bipolar disorder in adults, as an adjunct to antidepressants for major depressive disorder in adults, and for the treatment of schizophrenia in patients ≥13 years of age.

For more information call (800) 321-1335 or visit www.abilify.com.