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Companies Submit NDA for Vortioxetine for Major Depressive Disorder

Clinical development program included more than 7,500 patients (Oct. 2)

Takeda Pharmaceutical Company Limited, based in Osaka, Japan, and H. Lundbeck A/S, based in Copenhagen, Denmark, jointly announced on October 2 that they have submitted a new drug application (NDA) to the FDA for the investigational agent vortioxetine (Lu AA21004) for the treatment of major depressive disorder (MDD) in adult patients.

Vortioxetine is under investigation as an antidepressant with multimodal activity that is believed to work through a combination of two complementary mechanisms of action: receptor-activity modulation and reuptake inhibition.

The NDA includes data from six short-term placebo-controlled studies — including one dedicated study in elderly patients — that support the efficacy of vortioxetine in a dose range of 5 mg to 20 mg per day. The efficacy of vortioxetine was also demonstrated in a long-term relapse-prevention study in MDD. The vortioxetine global clinical development program included more than 7,500 individuals exposed to the drug.

MDD — commonly known as major depression — is a debilitating illness affecting approximately 121 million people worldwide, according to the World Health Organization (WHO). A landmark, long-term U.S. government study evaluating depression treatment (STAR*D) showed that only a third of patients with MDD achieve remission at the first stage of treatment. Each additional unsuccessful course of therapy is associated with a progressively lower likelihood of remission and higher relapse rates.

In vitro studies indicate that vortioxetine is a 5-HT3 and 5-HT7 receptor antagonist, a 5-HT1B receptor partial agonist, a 5-HT1A receptor agonist, and a serotonin transporter (SERT) inhibitor. In vivo nonclinical 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 mg to 20 mg, the most commonly observed adverse reactions in MDD patients treated with vortioxetine in placebo-controlled studies included nausea, constipation, and vomiting. Overall, 6.5% of vortioxetine-treated patients discontinued treatment because of an adverse reaction, compared with 3.8% of placebo-treated patients. Nausea was the most common adverse reaction reported as a reason for discontinuation and was considered to be drug-related.

For more information, visit the Takeda Web site.

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