H Lundbeck A/S (Lundbeck), a global pharmaceutical company specialized in brain diseases has, has launched its novel antidepressant Brintellix (vortioxetine) in Denmark. This marks the first European launch and thereby the next step in the global introduction of Brintellix, which was commercially launched in the US in January 2014. Following the Danish launch, Brintellix, which is approved for treatment of major depressive episodes (MDE, hereafter referred to as "depression") in adults, will be introduced in several other European and International Markets during 2014 and 2015.
This is the first time in five years that a new antidepressant drug becomes available in Denmark where 150,000 people suffer from depression. Brintellix will be available and reimbursed in Denmark as second line treatment for depression, in line with the reimbursement dossier submitted and approved by Danish health authorities.
Brintellix is a novel multimodal antidepressant, which has demonstrated significant efficacy in adult patients with depression as measured by traditional scales like MADRS or HAMD. It has also demonstrated improvement of cognitive performance in adult patients with depression, as measured with neuropsychological tests, as e.g. DSST or RAVLT. Cognitive symptoms are part of the diagnostic criteria for depression, and include the ability to concentrate, make decisions and the ability to remember. Cognitive symptoms are both part of the acute depressive episode as well as often being a residual symptom of depression. This means that patients with depression may have difficulties performing their duties at work. As a lot of people with depression are working, this loss of productivity is very costly for the society.
"When someone suffers from depression, the daily life of that person is severely affected, at home and in the workplace. Depression is a complex disease that involves mood, physical and cognitive symptoms. We are pleased to be able to offer a new treatment option to patients with depression," says Ole Chrintz, group senior vice president of International Markets and Europe at Lundbeck.
Brintellix is an inhibitor of serotonin (5-HT) reuptake and is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. Brintellix is considered to be the first and only compound with this combination of pharmacodynamic activity, although the mechanism of the antidepressant effect of Brintellix is not fully understood.
Vortioxetine was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in the US was conducted jointly by Lundbeck and Takeda, and Takeda holds marketing authorization for the US market. Brintellix is a trademark of H. Lundbeck A/S and is used under license by Takeda Pharmaceuticals America, Inc.
The World Health Organization has issued an Anatomical Therapeutic Chemical (ATC) code for Brintellix that places it in the category of "Other" antidepressants.