ABILIFY(R) (aripiprazole) Demonstrated Efficacy as Long-Term Maintenance Therapy in Adults With Bipolar I Disorder Following Treatment for a Recent Manic Or Mixed Episode.

- Longest Study to Date in Bipolar I Disorder With ABILIFY -

PRINCETON, N.J., and TOKYO, Dec. 7 /PRNewswire-FirstCall/ -- Maintenance therapy with the Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. atypical antipsychotic ABILIFY(R) (aripiprazole) for nearly two years significantly delayed time to relapse in adults with Bipolar I Disorder who had a recent manic or mixed episode and were then stabilized with the medication for at least six weeks, according to findings published in a supplement to Neuropsychopharmacology. The results - from the longest double-blind, randomized, placebo-controlled study reported to date investigating the treatment of Bipolar I Disorder with ABILIFY - were based on rigorous criteria used to define stability for Bipolar I Disorder.

"Bipolar I Disorder is a lifelong episodic illness. These findings are important because they support existing ABILIFY data for delaying the recurrence of mood symptoms," said Roger S. McIntyre, MD, Head, Mood Disorders Psychopharmacology Unit, University Health Network, Associate Professor of Psychiatry and Pharmacology, University of Toronto. "In fact, a recent study showed that nearly 50 percent of individuals who responded to initial treatment had relapses within two years, underscoring the importance of long- term maintenance treatment."

Bipolar I Disorder can be treated with antipsychotic medications. ABILIFY is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder, and for maintaining efficacy in adults with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least six weeks. ABILIFY is one of only two atypical antipsychotics indicated for maintenance therapy in Bipolar I Disorder. Physicians who elect to use ABILIFY(R) (aripiprazole) for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Study Design and Findings

In this double-blind, randomized, placebo-controlled long-term study, adults with Bipolar I Disorder who had recently been hospitalized and treated for a manic or mixed episode were initially stabilized with ABILIFY monotherapy (15 or 30 mg/day for 6-18 weeks). In the…