This approval was based on a comprehensive global clinical trial program which included six positive 6–8 week short-term studies, including one study in the elderly.
The primary efficacy measure was the mean change from baseline to endpoint in the Hamilton Depression Scale (HAMD-24) total score in two short-term studies, including the elderly study, and the Montgomery-Asberg Depression Rating Scale (MADRS) total score in the other studies.
In addition, the program included a positive 24–64 week long-term maintenance study in which Brintellix treatment resulted in a statistically significant longer time to recurrence of depressive episodes (defined as a MADRS total score ≥22 or as judged by the investigator) compared to placebo.
The mechanism by which vortioxetine exerts its antidepressant effects is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin.
Vortioxetine 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 these activities to the antidepressant effect of vortioxetine has not been established.
Brintellix is expected to be available by the end of 2013 in 5mg, 10mg and 20mg tablets.