Trial success for Lundbeck
10.04.2013 - In a thorough comparison, Lundbeck's new antidepressant Brintellix shone brightly: On a system for rating depression patients performed better.
Danish H. Lundbeck A/S reported on positive results for the REVIVE study, a double-blind randomised study of Brintellix (vortioxetine) in adults with major depressive disorder (MDD) who changed antidepressant treatment after an inadequate response to SSRI or SNRI treatment. In this study, the objective was to compare the efficacy and tolerability of flexible dose treatment with Brintellix (10-20mg/day) versus Servier's agomelatine (25-50mg/day) in this challenging MDD patient population. "Patients with inadequate response to current SSRI or SNRI therapies represent a large proportion of patients suffering from major depression. Only a few years ago, the landmark STAR*D study1 confirmed a significant unmet medical need, as only half of patients responded to their first-line treatment, which was an SSRI," said Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck. The US-American FDA accepted an NDA from Lundbeck and its partner Takeda on Brintellix last December.
Brintellix is under investigation as a multimodal antidepressant thought to work through a combination of two complementary mechanisms of action: receptor activity modulation and reuptake inhibition. In vivo non-clinical studies have demonstrated that Brintellix modulates neuronal firing and neurotransmitter release in multiple systems, resulting in enhanced levels of serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain. The multimodal activity profile of Brintellix is different from the profile of currently anti-depressive medicines.