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FDA approves Abilify (aripiprazole) as an add-on treatment for major depression

The U.S. Food and Drug Administration (FDA) has approved 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. Abilify is made by Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd.

“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 antidepressant therapies in the current episode and then added Abilify to their treatment regimens.

Major depressive disorder affects millions of U.S. adults at some point in their lives.(2) A recent study evaluated different treatment approaches, including adjunctive medications and switching strategies, in patients with MDD.(1) The study found that 63 percent of patients did not achieve adequate relief of depressive symptoms following the initial treatment with an antidepressant alone.(1) Additionally, the study demonstrated that the use of adjunctive medications in treatment may be useful to improve unresolved depressive symptoms.(1)

About Abilify® (aripiprazole)
The first and only available dopamine partial agonist, Abilify is indicated as adjunctive treatment to antidepressant therapy in adults with major depressive disorder.

Initially approved in November 2002, over 12.5 million prescriptions have been written for Abilify in the U.S.(10) through June 2007.

Abilify is available by prescription only. Abilify Tablets should be taken once daily with or without food and are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths. As adjunctive treatment to antidepressant therapy in adults with major depressive disorder, Abilify Oral starting dose is 2 mg/day to 5 mg/day with a maximum dose of 15 mg/day. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than one week.

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