U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Diso...(Ph.D. Executive Vice President Chief Sci...)

"We are pleased that ABILIFY has achieved this important milestone as the first medication approved as adjunctive treatment for adults with major depressive disorder," said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc. "This new add-on treatment option for depression represents hope for many adults suffering from this debilitating illness."

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)

Clinical Trial Design and Findings

Two six-week, double-blind, randomized, placebo-controlled, multicenter studies evaluated the efficacy and safety of add-on ABILIFY in adult patients with a primary diagnosis of major depressive disorder who had experienced an inadequate response to prior antidepressant therapy (one to three courses) in the current episode.

After an eight-week prospective treatment phase with one ADT plus single- blind placebo to confirm inadequate response to ADT, 743 participants entered a six-week randomized treatment phase during which they continued their ADT plus double-blind adjunctive placebo or adjunctive ABILIFY. All study participants received one of the commonly prescribed
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