Lundbeck has presented promising data on Brintellix, its recently-filed investigational antidepressant co-developed with Takeda.
The Danish drugmaker announced results for the REVIVE study which compared Brintellix (vortioxetine) with Servier’s Valdoxan (agomelatine), Servier’s in adults with major depression (MDD) who changed antidepressant after an inadequate response to commonly-prescribed selective serotonin reuptake inhibitors (SSRIs) or serotonin–norepinephrine reuptake inhibitors (SNRIs). Lundbeck noted that as one of the newest antidepressants, agomelatine was chosen as a comparator because of its different mode of action from conventional SSRI/SNRI therapies.
Lundbeck noted that few randomised, double-blind trials looking at MDD patients who were unresponsive to first-line antidepressants have been conducted and “this is one of these few studies which also shows a significant difference between treatments.” On the primary efficacy endpoint for REVIVE, Brintellix was statistically significantly superior to agomelatine by 2.2 points on the Montgomery–Asberg Depression Rating Scale (MADRS), a ten-item questionnaire used to measure severity of the disorder.
Anders Gersel Pedersen, head of R&D at Lundbeck, said that “patients with inadequate response to current SSRI or SNRI therapies represent a large proportion of patients suffering from major depression” and a few years ago, a landmark study, STAR*D, “confirmed a significant unmet medical need as only half of patients responded to their first-line treatment, which was an SSRI.
Brintellix is under review on both sides of the Atlantic and is one of three new products, Lundbeck hopes to launch this year. The other two, which are already approved in some territories, are its once-monthly version of Abilify (aripiprazole) for schizophrenia and the alcohol dependence treatment Selincro (nalmefene); indeed, Lundbeck also presented new data on the later from three Phase III studies that “consistently show a significant reduction in alcohol consumption” in patients with high-risk drinking levels.
