PRINCETON, N.J. and TOKYO The Food and Drug Administration has approved the supplemental application for Abilify, made by Bristol-Myers Squibb and Otsuka Pharmaceutical, as an add-on treatment for antidepressant therapy in adults with major depressive disorder.
The approval is based on results from two six-week, double-blind, randomized, placebo-controlled, multi-center studies. The results from both studies showed 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.
“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, 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.”
Abilify is regularly indicated for the treatment of schizophrenia and manic episodes associated with Bipolar I Disorder.