FDA approves update to label for Trintellix in depression.- Lundbeck.

Lundbeck announced the FDA approved a supplemental new drug application for Trintellix (vortioxetine). The clinical trials section of the U.S. label now includes data from the largest replicated clinical studies on an important aspect of cognitive function in acute major depressive disorder (MDD, depression). The FOCUS and CONNECT studies show Trintellix has a positive effect on processing speed, an important aspect of cognitive function observed in some patients with MDD.

The new data in the label are from the FOCUS and CONNECT studies, which were specifically designed to assess the effect of Trintellix on certain aspects of cognitive dysfunction in adult patients (18-65 years) with depression. These two eight-week, randomized, double-blind, placebo-controlled studies of Trintellix 10 and 20 mg/day used a neuropsychological measure, known as the Digit Symbol Substitution Test (DSST). The DSST is a neuropsychological test that most specifically measures processing speed, an aspect of cognitive function that may be impaired in MDD. The effects observed on DSST may reflect improvements in depression. Comparative studies have not been conducted to demonstrate a therapeutic advantage over other antidepressants on the DSST.

Comment: The FDA approved Trintellix on 30 September 2013 for the treatment of MDD in adults. Vortioxetine is furthermore approved in 77 countries (including Europe, Canada, Chile, China, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore and South Africa). It is available in more than 60 countries to date. Outside North America, vortioxetine is recognized as Brintellix