FDA approves Brintellix for Major Depressive Disorder

H. Lundbeck A/S and Takeda Pharmaceutical Company Limited jointly announced that the FDA has on 30 September 2013 approved Brintellix (vortioxetine) for the treatment of adults with Major Depressive Disorder (MDD), a debilitating mental health illness affecting approximately 14 million adult Americans in a given year. The mechanism of the antidepressant effect of Brintellix is not fully understood. 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 Brintellix's antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity. The clinical relevance of this is unknown.

The efficacy and safety of Brintellix were established across a comprehensive global clinical trial program, including six positive 6-8 week short-term studies � one of which was a dedicated study in the elderly that demonstrated statistically significant improvements in overall symptoms of depression.