Takeda and Lundbeck announced that the Food and Drug Administration (FDA)’s Psychopharmacologic Drug Advisory Committee (PDAC) voted in favor (8-2) to support the efficacy of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). The FDA panel also discussed that cognitive function in MDD represents an appropriate therapeutic target.
The Advisory Committee reviewed data from two 8-week, randomized, double-blind, placebo-controlled studies, FOCUS and CONNECT, that evaluated the efficacy of Brintellix on certain aspects of cognitive dysfunction in adults aged 18-65 years with MDD. These trials evaluated Brintellix 10mg/day and 20mg/day using a neuropsychological test of cognitive performance (DSST).
Brintellix is currently indicated for the treatment of MDD. It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. It is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of each of these activities to its antidepressant effect has not been established. It is available as 5mg, 10mg, 15mg, and 20mg strength tablets.
The Advisory Committee presents the FDA with independent expert advice and recommendations but the FDA is not bound by the committee’s guidance. The Agency is expected to make a decision by March 28, 2016.
For more information call (877) 825-3327 or visit Brintellix.com.