PRINCETON, NJ and TOKYO, JAPAN, November 20, 2007 Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY(R)(aripiprazole) as adjunctive, or add-on, treatment to antidepressant therapy (ADT) in adults with major depressive disorder (MDD). ABILIFY is the first medication approved by the FDA as add-on treatment for MDD.
The approval of this new add-on treatment option is critical for adults suffering from depression who cannot find sufficient relief for their symptoms with antidepressants alone, said Madhukar Trivedi, M.D., Professor and Chief-Division of Mood Disorders, University of Texas Southwestern Medical School, Dallas, Texas. Now physicians have a proven new option they can add to their patients antidepressant treatments to help them feel better and relieve unresolved depressive symptoms.
The approval is based on results from two six-week, double-blind, randomized, placebo-controlled, multicenter studies (n=743). The results from both studies demonstrated significant improvement in depressive symptoms in adult patients with a primary diagnosis of major depressive disorder who had experienced an inadequate response* to monotherapy with one or more ADTs in the current episode and then added ABILIFY to their treatment regimens.
We are committed to helping those who suffer from depression, one of the leading causes of disability in the United States and worldwide, said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. This approval is a reflection of our ongoing commitment to provide innovative therapies, such as ABILIFY, to help adults living with depression.
We are pleased that ABILIFY has achieved this important milestone as the first medication approved as adjunctive treatment for
|Contact: David M. Rosen|