FDA updates Trintellix label

Takeda Pharmaceutical Company Limited and H. Lundbeck A/S announced the FDA approved their supplemental new drug application for Trintellix, which will now include labeling data on processing speed improvement in acute major depressive disorder, according to the press release.

Two 8-week, randomized, double-blind, placebo-controlled studies, FOCUS and CONNECT, showed Trintellix (vortioxetine) had a positive effect on processing speed in adults with acute MDD, according to the press release. Vortioxetine is now the first antidepressant with labeling recognizing Digit Symbol Substitution Test (DSST) data as a clinically meaningful measure in acute MDD.

According to the release, the effects determined by the DSST may reflect improvement in depression; however, comparative studies have not been conducted to demonstrate a therapeutic advantage over other antidepressants on this neuropsychological 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,” Gregory Mattingly, MD, associate clinical professor, department of psychiatry, Washington University School of Medicine, said in the press release. “This updated [vortioxetine] labelling regarding improvement in processing speed provides important information to improve discussions between health care providers and patients about their depression.”

Disclosures: Healio Psychiatry was unable to confirm any relevant financial disclosures at the time of publication.