Lundbeck announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Trintellix (vortioxetine) to include data regarding improved processing speed, an important aspect of cognitive function that may be impaired in patients with major depressive disorder (MDD).
The approval was based on data from the 8-week, randomized, double-blind, placebo-controlled studies, FOCUS and CONNECT, which investigated the effect of Trintellix on various aspects of cognitive function among adults aged 18 to 65 years with depression. Study patients were given Trintellix 10mg, 20mg or placebo daily and assessed via the Digit Symbol Substitution Test (DSST), a neuropsychological measure that evaluates processing speed.
In both studies, patients treated with Trintellix had a statistically significantly greater improvement in the number of correct responses on the DSST vs placebo. In addition, depressed mood as assessed by change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score also improved in both studies. The positive effects seen on the DSST may reflect improvement in depression.
Trintellix, a serotonergic agonist and antagonist, was approved by the FDA in September 2013 for the treatment of adults with MDD. Its mechanism is thought to be related to the enhancement of serotonergic activity in the central nervous system (CNS) through inhibition of serotonin reuptake.
Trintellix is available as 5mg, 10mg, and 20mg strength tablets in 30-, 90-, and 500-count bottles.
For more information call (877) 825-3327 or visit Trintellix.com.