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news.Bristol-Myers Squibb and Otsuka Pharmaceutical Co's Abilify has been granted FDA approval for a new indication in bipolar I disorder.
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Abilify (aripiprazole) tablets and oral solution have been approved for maintaining efficacy in patients with bipolar I disorder with a recent manic or mixed episode, who had been stabilized and then maintained for at least six weeks.
The latest FDA approval is based on the positive results of a trial designed to compare the maintenance of efficacy of Abilify versus placebo, measured by time to relapse.
Results demonstrated that patients stabilized on Abilify for at least six weeks experienced a significant delay in time to relapse compared to those receiving placebo. However, there is insufficient data to know whether Abilify is effective in delaying the time to occurrence of depression in patients with bipolar I disorder.
“This approval of Abilify is important news for patients who suffer from bipolar I disorder with manic and mixed episodes, as relapse is unfortunately, very common,” said Dr John Zajecka, director of the Treatment Research Center and associate professor of psychiatry at Rush University Medical Center. “As a physician, it is very encouraging to know that patients can benefit from Abilify (aripiprazole) throughout the different phases of their treatment.”
The FDA approved Abilify for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder, on September 29, 2004.