Bristol-Myers Squibb and Otsuka announced that Abilify (aripiprazole) has been approved by the FDA as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder. This approval was based on results from a randomized, double-blind, placebo-controlled study 52-week maintenance trial of Abilify and lithium or valproate in patients meeting DSM-IV criteria for Bipolar I Disorder. Study data showed adjunctive Abilify to be superior to adjunctive placebo on the primary study endpoint of time from randomization to relapse to any mood event. Mood events were defined as hospitalization for a manic, mixed or depressive episode, study discontinuation due to lack of efficacy (accompanied by Y-MRS and/or MADRS score >16), or a serious adverse event of worsening disease (accompanied by Y-MRS and/or MADRS score >16).

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