This is the first FDA-approved antidepressant for MDD to have data in US Prescribing Information showing a positive effect on processing speed.
The US labeling for Takeda Pharmaceutical Company’s vortioxetine (TRINTELLIX) now includes data from the largest replicated clinical studies (FOCUS and CONNECT) demonstrating an improvement in processing speed among patients, an important aspect of cognitive function that may be impaired in adults with acute major depressive disorder (MDD).
Additionally, Takeda announced the US Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTEXLLIX.
This is the first FDA-approved treatment for MDD to include data in the US Prescribing Information from the largest replicated clinical studies that showed a positive effect on processing speed. The FDA approved TRINTELLIX Sept. 30, 2013, for the treatment of MDD in adults.
FOCUS and CONNECT, the 2 8-week studies, were designed to assess the effect of 10 and 20 mg/day TRINTELLIX on specific aspects of cognitive dysfunction in adult patients (18—65 years) with depression. The studies used the neuropsychological measure, Digit Symbol Substitution Test to specifically measure processing speed during treatment of acute MDD.
“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,” Gregory Mattingly, MD, associate clinical professor, Washington University School of Medicine, said in a statement. “As part of a comprehensive treatment approach, it’s important for clinicians to talk to patients about all symptoms associated with depression. This updated TRINTELLIX labeling regarding improvement in processing speed provides important information to improve discussions between health care providers and patients about their depression.”
The most commonly observed adverse effects with an incidence ≥ 5% and at least twice the rate of placebo were nausea, constipation and vomiting. Overall, 5—8% of the patients who received the 5 to 20 mg/day treatment in short-term trials discontinued treatment due to an adverse effect, with the most common being nausea, compared to 4% of placebo-treated patients in the studies.
Recommended starting dose is 10 mg once daily without regard to meals. Doses should be then increased to 20 mg/day, as tolerated, however, a dose decrease to 5 mg/day may be considered for those who cannot tolerate higher doses.
TRINTELLIX is available as 5 mg, 10 mg and 20 mg tablets.
Vortioxetine is also approved in 77 countries and is available in more than 60 countries to date, recognized as Brintellix outside North America.