Earlier this month the U.S Food and Drug Administration approved Abilify for the treatment of schizophrenia in teens and have now expanded that approval to include patients with major depressive disorder.
Approved in 2002 for schizophrenia in adults and for adults suffering from bipolar manic episodes, Bristol-Myers Squibb states that Abilify is the first drug approved as an adjunctive treatment for major depressive disorder for patients needing more than just antidepressants.
"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," commented Madhukar Trivedi, M.D., of the University of Texas Southwestern Medical School in Dallas.
Supplemental approval was granted based on information from two studies that found that adults with major depressive disorder who were treated with Abilify and antidepressants had a greater improvement rate, after 6 weeks, than those treated with an antidepressant and placebo.
The most common side effects associated with the adjunctive therapy were akathisia, restlessness, insomnia, constipation, fatigue and blurred vision. Other side effects included neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and diabetes, hypotension and seizure.
The study was funded by Bristol-Myers Squibb and the authors are employees of the company. Complete details are available at MedPageToday.
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