De gids voor de geestelijke gezondheidszorg

New Antidepressant Receives EU Approval

31 December 2013

Vortioxetine (Brintellix, Takeda Pharmaceuticals and Lundbeck), an investigational multimodal antidepressant thought to work through a combination of 2 pharmacologic modes of action ― serotonin (5-HT) receptor activity modulation and 5-HT reuptake inhibition ― has been approved in September by the US Food and Drug Adminstration (FDA) for major depressive disorder in adults and recently by the EU Commission.

The approval in the US was based on safety and efficacy data from 6 multicenter, randomized, double-blind, parallel group trials of adult patients testing doses of vortioxetine ranging from 5 to 20 mg/day compared with placebo.The drug's approval in the EU was based on data from 12 short-term, placebo-controlled trials involving 4000 patients with an acute episode of major depression. 

The recommended starting and treatment dose of Brintellix is 10 mg once daily in adults younger than 65 years. The dose may be increased to a maximum of 20 mg once daily or decreased to a minimum of 5 mg once daily, depending on individual patient response.

The most common side effects included nausea, headache, diarrhea, dizziness, constipation, vomiting, fatigue, and viral upper respiratory infection.


FDA Approves Vortioxetine for Major Depression 
New Antidepressant Receives EU Approval
Experimental Antidepressant Moves Closer to US Approval





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