Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) jointly announced that the U.S. Food and Drug Administration (FDA) has approved Brintellix (vortioxetine) for the treatment of adults with major depressive disorder (MDD).
The mechanism of the antidepressant effect of Brintellix is not yet fully understood:
- It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action.
- It is 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.
"MDD is a multifaceted disorder that encompasses emotional, physical and cognitive symptoms that may make it challenging to treat," said Michael Thase, M.D., professor of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania. "Because patients respond to treatments differently, it is important to have additional new options available to help address the overall symptoms of major depression."
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. 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 clinical trial 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. Studies evaluated for safety included more than 4,700 patients aged 18 to 88 years. It is expected that Brintellix will be available to patients by year end 2013.
"There are very few new antidepressant drugs currently in development even though so many patients still struggle with depression. We are excited about the approval of Brintellix and being able to offer a new option for patients," said Anders Gersel Pedersen, executive vice president and head, Research and Development at Lundbeck.