Abilify (aripiprazole) granted approval for new indication
PRINCETON, N. J. & TOKYO, JAPAN, March 7, 2005 -- Bristol-Myers Squibb and Otsuka Pharmaceutical announced that the FDA has approved Abilify (aripiprazole) Tablets and Oral Solution for maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode, who have been stabilized and then maintained for at least six weeks.
Abilify was originally approved 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. Physicians who elect to use Abilify for extended periods, that is, longer than six weeks, should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
The latest FDA approval is based on the positive results of a randomized, double-blind, multicenter, 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 (p-value equals 0.020). In addition, the total number of relapses was significantly fewer in patients treated with Abilify than with placeboiv (25 percent versus 43 percent, 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 adverse events reported during this trial were generally consistent with those reported in other long-term placebo-controlled trials of Abilify.
Abilify is indicated for the treatment of schizophrenia, acute manic and mixed episodes associated with bipolar disorder, and now 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. Since its initial approval in 2002, over 3.7 million prescriptions have been written in the United States.
Abilify is available by prescription only. In addition to administration as a once-daily oral tablet, Abilify was recently FDA-approved in an oral solution formulation. Now available in U.S. pharmacies, Abilify Oral Solution is an important new treatment option for adult patients who are unable to or have difficulty swallowing tablets, and provides flexibility in addressing individual patient needs. Patients should talk to their health care provider for more information. To learn more about Abilify and for full product information, visit www.Abilify.com
Source: Bristol-Myers Squibb
Posted: March 2005