Vortioxetine Label Updated to Include Gain in Processing Speed
The US Food and Drug Administration (FDA) has approved a supplemental new drug application for vortioxetine (Trintellix), the pharmaceutical company Lundbeck recently announced. The drug’s label will be updated to mention studies showing improved processing speed associated with vortioxetine in patients with major depressive disorder (MDD).
Specifically, the label’s clinical trials section will include data from the FOCUS and CONNECT studies that showed a positive effect on processing speed linked with the drug. The pair of 8-week, randomized, double-blind, placebo-controlled studies assessed the effect of vortioxetine 10 mg/day and 20 using the Digit Symbol Substitution Test, a neuropsychological measure.
The effects on processing speed may reflect improvements in depression, according to Lundbeck. Comparative studies have not been conducted to investigate whether vortioxetine has a therapeutic advantage over other antidepressants on the Digit Symbol Substitution Test.
“Many of my MDD patients recognize the mood and physical attributes of depression, but do not often recognize that their cognitive symptoms may also be part of their depression. As part of a comprehensive treatment approach, it's important for clinicians to talk to patients about all symptoms associated with depression,” said Gregory Mattingly, MD, Washington University School of Medicine, St. Louis, Missouri.
“This updated Trintellix labelling regarding improvements in processing speed provides important information to improve discussions between healthcare providers and patients about their depression,” Dr. Mattingly said.
FDA updates Trintellix (vortioxetine) label to include data showing improvement in processing speed, an important aspect of cognitive function in acute major depressive disorder (MDD) [press release]. Valby, Denmark: Lundbeck; May 2, 2018.