FDA Approves ABILIFY for Add-On Treatment to Lithium or Valproate

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. have announced that the FDA has approved updated labeling for ABILIFY&reg (aripiprazole) 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 monotherapy for the treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004. In addition to this new indication, 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. 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). At study endpoint (Week 6), 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 approval of the starting dose of 15 mg daily for ABILIFY is based on results from two three-week, randomized, double-blind, placebo-controlled studies in adults with manic or mixed episodes of Bipolar I Disorder. At study endpoint (Week 3), ABILIFY was superior to placebo in the reduction of the Y-MRS Total Score and CGI-BP Severity of Illness Score for Mania. “Expanding the clinical use of ABILIFY gives patients with Bipolar I Disorder a new treatment option,” said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. “Our mission at Otsuka is to develop products to their fullest potential,” said Hiromi Yoshikawa, Chairman and Chief Executive Officer, Otsuka America Pharmaceutical, Inc. “The approval of this new indication for ABILIFY provides another option for physicians that helps address the needs of their patients.”