H. Lundbeck A/S (Lundbeck) has announced that the US Food and Drug Administration (FDA) has accepted the submission of a New Drug Application (NDA) for BrintellixTM (vortioxetine) for the treatment of major depressive disorder (MDD) in adult patients. BrintellixTM (pronounced “brin′-tel-ix”) is the proposed global trade name for vortioxetine.
According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is targeted for completion by 2 October, 2013.
The NDA includes positive data from six short-term studies and one long-term maintenance study. The vortioxetine global clinical development program included more than 7,500 individuals aged 18 to 88 years old exposed to the drug. Major depression, often referred to as depression, is a common, debilitating illness affecting around 15 million Americans and 121 million people worldwide. Depression was the third leading contributor to the global burden of disease in 2004 and is projected to be the leading contributor to the worldwide burden of disease by 2030.
Brintellix (vortioxetine) is under investigation as an antidepressant with multimodal activity that is thought to work through a combination of two mechanisms of action: receptor activity modulations and reuptake inhibition.
In vitro studies indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the serotonin (5-HT) transporter (SERT). In vivo non-clinical studies have demonstrated that vortioxetine enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain.
Across the doses of 5–20mg, the most commonly observed adverse reactions in MDD patients treated with vortioxetine in placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting. Overall, 6.5% of the patients who received vortioxetine discontinued treatment due to an adverse reaction, compared with 3.8% of placebo-treated patients in these studies. Nausea was the most common adverse reaction reported as a reason for discontinuation and considered to be drug-related.