Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. received approval from the FDA for updated labeling for Abilify as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults. Abilify has been approved as a monotherapy for the treatment Bipolar I Disorder in adults since September 2004.
The approval of Abilify used in combination with lithium or valproate is based on results from a six-week, randomized, double-blind, placebo-controlled study in adults with manic or mixed episodes of Bipolar I Disorder who had an inadequate response to a two-week, lead-in phase of mood stabilizer monotherapy (lithium or valproate). The study showed that add-on Abilify was superior to lithium or valproate with adjunctive placebo in the reduction of the Young-Mania Rating Scale (Y-MRS) Total Score and the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score for Mania.
The FDA also approved a new recommended starting and target dose of 15 mg daily for Abilify monotherapy in the treatment of Bipolar I Disorder in adults. This approval is based on results from two randomized, double-blind, placebo-controlled studies in adults with manic or mixed episodes of Bipolar I Disorder. The study showed that Abilify was superior to placebo in the reduction of the Y-MRS Total Score and CGI-BP Severity of Illness Score for Mania.