The U.S. Food and Drug Administration (FDA) today announced that it has approved vortioxetine, a new medication to treat major depressive disorder in adults. The drug is marketed by both Takeda Pharmaceuticals and Lundbeck as Brintellix, and will come in 5 mg, 10 mg, 15 mg, and 20 mg tablets.
The drug was approved following six clinical trials which showed the medication was successful in treating depression. A seventh study also showed that, after treatment with Brintellix, patients may see a decrease the chance of becoming depressed again.
“Major depressive disorder can be disabling and can keep a person from functioning normally,” said Dr. Mitchell Mathis, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression.”
As a serotonin modulator, Brintellix's side effects were found to be similar to those of other antidepressants. During the trials the most common side effects identified were nausea, constipation, and vomiting. In addition, Brintellix will carry the same box warning as other antidepressants, warning that antidepressants have been found to increase the risk of suicidal thoughts in children, teens, and young adults up to the age of 24.