Vortioxetine receives FDA approval for major depressive disorder

The FDA has announced approval of vortioxetine for the treatment of major depressive disorder in adults. The drug will be available in 5-mg, 10-mg, 15-mg and 20-mg tablets, according to an agency press release.

Approval is based on data from six randomized trials of adults with major depressive disorder (MDD). Vortioxetine (Brintellix, Takeda) was effective in treating MDD compared with placebo, and an additional study demonstrated the drug decreased the likelihood for future depression. During the trials, side effects included nausea, constipation and vomiting.

Along with other antidepressants, vortioxetine comes with a boxed warning and medication guide to notify patients and providers of the risk for suicidal thoughts and behavior in children, adolescents and young adults (aged 18 to 24) during initial treatment. According to the press release, the excess risk has not been demonstrated in adults older than 24 years, and people aged 65 and older seem to have a lower risk for suicidal thoughts and behavior. The FDA cautions, however, that all patients beginning treatment with antidepressants should be closely monitored for suicidal thoughts and behavior and worsening of their depression.

"Major depressive disorder can be disabling and can keep a person from functioning normally," Mitchell Mathis, MD, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in the press release. "Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression."