FDA Approves New Antidepressant — Physician’s First Watch
FDA Approves New Antidepressant
By Kristin J. Kelley
The FDA has approved vortioxetine (marketed as Brintellix) for adults with major depressive disorder. The drug has several mechanisms of action, including receptor activity modulation and reuptake inhibition, and does not appear to impair psychomotor performance.
Vortioxetine was effective in treating depression in six clinical trials. Additionally, in another study, patients randomized to vortioxetine had driving performances similar to those on placebo.
Like all antidepressants, vortioxetine will carry a boxed warning about the increased risk for suicidality during the early phase of treatment in patients up to age 24. Commonly reported side effects include constipation, nausea, and vomiting. The tablets will be available in 5-, 10-, 15- and 20- mg doses.