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Bristol-Myers Squibb's aripiprazole (Abilify) is approved for use in the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar mania. Aripiprazole was previously approved for the treatment of schizophrenia.

 

The FDA based the approval on clinical trials showing that the medication significantly improved symptoms compared with placebo in patients with bipolar I disorder who are experiencing an acute manic or mixed episode. The most common side effects reported in clinical trials were akathisia, constipation, and accidental injury. The rate of discontinuation due to side effects was low. There were no significant differences compared with placebo with respect to weight gain, blood sugar levels, or lipids.