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FDA Accepts NDA Submission for New Antidepressant Drug, Vortioxetine

Approval decision expected in October 2013 (Dec. 13)

The FDA has accepted for filing the submission of a new drug application (NDA) for vortioxetine (formerly Lu AA21004, Takeda/Lundbeck) for the treatment of major depressive disorder (MDD) in adults. Review of the NDA is expected to be completed by October 2, 2013.

The NDA includes positive data from six short-term studies and one long-term maintenance study involving more than 7,500 adult patients aged 18 to 88 years. MDD, commonly referred to as major depression, is a debilitating illness affecting approximately 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.

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 modulation and reuptake inhibition.

In vitro studies have indicated that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, a 5-HT1B receptor partial agonist, and a 5-HT1A receptor agonist/inhibitor of the serotonin (5-HT) transporter (SERT). In vivo nonclinical studies have demonstrated that vortioxetine increases levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine, and histamine in specific areas of the brain.

At doses of 5 to 20 mg, the most commonly observed adverse events (AEs) in MDD patients treated with vortioxetine in placebo-controlled studies were nausea, constipation, and vomiting. Overall, 6.5% of patients who received vortioxetine discontinued treatment because of an AE, compared with 3.8% of placebo-treated patients. Nausea was the most common AE reported as a reason for discontinuation and considered to be drug-related.

The proposed global trade name for vortioxetine is Brintellix, pending final acceptance by the FDA and other regulatory agencies.

Source: Lundbeck; December 12, 2012.

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