FDA Approves New Indication for Schizophrenia Treatment Abilify

The FDA has approved a new indication for Bristol-Myers Squibb's and Otsuka Pharmaceutical's schizophrenia drug Abilify, clearing it for treatment of Bipolar I Disorder patients with a recent manic or mixed episode who had been stabilized and then maintained for at least six weeks.

The new indication was supported by clinical data that demonstrated that patients who had been stabilized on Abilify (aripiprazole) for at least six weeks experienced a significant delay in time to relapse, the primary outcome measure for the study, as compared with those randomized to placebo.

The drug is already approved for treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder.