The U.S. Food and Drug Administration approved the supplemental New Drug Application for Abilify (aripiprazole) as adjunctive, or add-on treatment to antidepressant therapy (ADT) in adults with major depressive disorder (MDD).

The drug was originally approved in 2002 for schizophrenia, as well as mixed episodes in adults suffering from bipolar I disorder. Abilify is the first drug approved by the FDA as add-on treatment for MDD, according to Bristol-Myers Squibb, which revealed the FDA decision. Both Bristol and Otsuka Pharmaceutical Co LTD of Japan sell the drug.

"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. 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," said Madhukar Trivedi, M.D., Professor and Chief- Division of Mood Disorders, University of Texas Southwestern Medical School, Dallas, Texas.

MDDs appear to affects millions of U.S. adults at some point in their lives. The FDA’s approval of the drug is a result of two short studies, one of them presented at the meeting of the American Psychiatric Association in May and published in the June issue of the Journal of Clinical Psychiatry. Robert M. Berman, M.D., of Bristol-Myers Squibb, conducted the second study.

Both studies evaluated different treatment approaches, including adjunctive medications and switching strategies. The study showed that 63 percent of patients suffering from MDD have not achieved any improvements by following the initial treatment with an antidepressant alone. Another founding of the study was that the use of adjunctive medications might improve unresolved depressive symptoms.

"We are committed to helping those who suffer from depression, one of the leading causes of disability in the United States and worldwide. This approval is a reflection of our ongoing commitment to provide innovative therapies, such as ABILIFY, to help adults living with depression," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb.