FDA Approves New Drug to Treat Major Depressive Disorder

Yesterday, the Food and Drug Administration (FDA) approved Brintellix (vortioxetine) to treat adults with major depressive disorder (MDD). The product, co-marketed by Takeda Pharmaceuticals and Lundbeck, will be available in 5 mg, 10 mg, 15 mg and 20 mg tablets. The FDA reviewed six clinical trials that found that Brintellix was more effective than placebo in alleviating depression and preventing illness relapse in participants with MDD. The most common side effects reported included nausea, constipation, and vomiting.

“Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression,” said Mitchell Mathis, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.

Similar to other antidepressant pharmacotherapies, Brintellix will carry a boxed warning for increased risk of suicidal thoughts and behavior in children, adolescents, and young adults aged 18 to 24 at treatment initiation. The FDA advises that, "Patients starting antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior."

For a description of Brintellix’s clinical trials and other FDA actions on psychoactive medications, see the Med Check section of Psychiatric News.

(Image Courtesy of ptccreative.com)