Bristol-Myers and Otsuka win FDA approval for Abilify

Posted on: Thu, 26 Nov 2009 08:17:00 EST


Symbols: BMY
Nov 26, 2009 (Datamonitor via COMTEX) --
BMY | Quote | Chart | News | PowerRating -- Bristol-Myers Squibb Company and Otsuka Pharmaceutical have reported that the FDA has approved the supplemental new drug application for Abilify for the treatment of irritability associated with autistic disorder in pediatric patients aged six to 17 years.

The approval of Abilify for this indication is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies in which Abilify, compared to placebo, significantly improved scores on the irritability subscale of the caregiver-rated aberrant behavior checklist (ABC-I), said Bristol-Myers.

The ABC-I subscale measured the emotional and behavioral symptoms of irritability in autistic disorder, including aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

Participating patients had a diagnostic and statistical manual of mental disorders diagnosis of autistic disorder, and exhibited behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.

The efficacy of Abilify for the maintenance treatment of irritability associated with autistic disorder has not been evaluated. While there is no body of evidence available to answer the questions of how long the patient treated with Abilify should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment, said Bristol-Myers.

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