Abilify approved for irritability associated with autistic disorder

The FDA has approved Abilify (aripiprazole, from Bristol-Myers Squibb and Otsuka) for the treatment of irritability associated with autistic disorder in pediatric patients 6–17 years of age, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. This approval was based on data from two Phase 3, multicenter, eight-week, randomized, double-blind, placebo-controlled studies in which Abilify, compared to placebo, significantly improved scores on the Irritability subscale of the caregiver-rated Aberrant Behavior Checklist (ABC-I).

Abilify is already indicated for the treatment of schizophrenia and for the acute and maintenance treatment of manic or mixed episodes in bipolar disorder as monotherapy; or as an adjunct to lithium or valproate. Abilify is also indicated as an adjunct to antidepressants for major depressive disorder.

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