Antidepressant Approved After Success in Elderly

Abstract

Vortioxetine, a new antidepressant, has been approved for treating major depressive disorder in adults. It is being marketed as Brintellix by Takeda Pharmaceuticals and Lundbeck, available in 5-mg, 10-mg, 15-mg, and 20-mg tablets. The Food and Drug Administration approved the drug last fall, and Lundbeck announced on Dec. 27 that it had obtained European marketing authorization for Brintellix. The mechanism of antidepressant effect “is thought to be related to its enhancement of serotonergic activity in the [central nervous system] through inhibition of the reuptake of serotonin (5-HT),” according to the prescribing information. In the FDA's approval statement, Mitchell Mathis, MD, said that since medi-cations affect everyone differently, “it is important to have a variety of treatment options available for patients who suffer from depression.” Dr. Mathis is acting director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research. Approval was based on six 6–8–week, randomized studies conducted in the United States and elsewhere, which found that treatment with at least one dose of the drug was more effective than placebo. Five of the studies enrolled patients aged 18–75 years, and one enrolled patients aged 64-88 years. In a long-term maintenance study, those treated with vortioxetine had a longer time to recurrence of depression than did those treated with placebo. Nausea, vomiting, and constipation were the most common adverse effects associated with the drug in clinical trials, according to the FDA statement. As with all antidepressant drugs, the prescribing information has a boxed warning and medication guide about the increased risk of suicidal thoughts and behavior in children, adolescents, and adults aged 18–24 years, during initial treatment. The warning includes the recommendation that people starting treatment with antidepressants be closely monitored for worsening depression and suicidal thoughts and behavior.