Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. jointly announced that the US FDA approved Abilify (aripiprazole) Tablets and Oral Solution 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 FDA approved Abilify for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder, on September 29, 2004.
Clinical data demonstrated that patients who had been stabilized on Abilify for at least six weeks experienced a significant delay in time to relapse, the primary outcome measure for this study, as compared with those randomized to placebo. The majority of these relapses were due to manic rather than depressive symptoms. There is insufficient data to know whether Abilify is effective in delaying the time to occurrence of depression in patients with Bipolar I Disorder, a BMS release says.
"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," John Zajecka, director, Treatment Research Centre said adding, "As a physician, it is very encouraging to know that patients can benefit from Abilify throughout the different phases of their treatment."
The latest FDA approval is based on the positive results of a randomized, double-blind, multi-centre, placebo-controlled trial designed to compare the maintenance of efficacy of Abilify versus placebo, measured by time to relapse. In this study, patients who had recently experienced a manic or mixed episode were first stabilized with Abilify for at least six consecutive weeks. After meeting the stabilization criteria [Young Mania Rating Scale Total Score (Y-MRS) less than or equal to 10 and Montgomery-Asberg Depression Rating Scale (MADRS) less than or equal to 13 during four consecutive visits over a minimum of six weeks], 161 patients were given Abilify or placebo in the double-blind, randomization phase.
The primary endpoint was time to relapse of manic and depressive symptoms. Of those patients who experienced a relapse, patients treated with Abilify relapsed significantly later than placebo-treated patients. In addition, the total number of relapses was significantly fewer in patients treated with Abilify than with placebo (25% Vs 43%, respectively; p-value equals 0.013). The majority of these relapses were due to manic rather than depressive symptoms. There is insufficient data to know whether Abilify is effective in delaying the time to occurrence of depression in patients with Bipolar I Disorder, the release said.
Abilify (aripiprazole) is indicated for the treatment of schizophrenia, acute manic and mixed episodes associated with bipolar disorder.