Takeda Global Research & Development Center and Lundbeck have announced the FDA acceptance of vortioxetine new drug application (NDA) filing for major depressive disorder.
The companies have also announced the proposal of Brintellix as the global trade name for vortioxetine.
Positive results obtained from six short-term studies and a long-term maintenance study were included in the NDA.
Vortioxetine was shown in vivo non-clinical studies, to increase neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine levels in certain part of the brain.
In vitro studies revealed that vortioxetine is a 5-HT3 and 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the serotonin (5-HT) transporter.
Vortioxetine (Lu AA21004) is being studied as an antidepressant that is believed to work by combining receptor activity modulations and reuptake inhibition.
The review of the NDA is targeted for completion by 2 October 2013, according to Lundbeck.
