Date: 2014-06-26
Type of information: Publication of results in a medical journal
phase:
Announcement: presentation of results at the Congress of the International College of Neuropsychopharmacology (CINP)
Company: Lundbeck (Denmark) Otsuka Pharmaceutical (Japan)
Product: Brintellix® (vortioxetine)
Action
mechanism: serotonin receptor agonist/serotonin receptor antagonist. 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. Vortioxetine was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in the U.S. was conducted jointly by Lundbeck and Takeda, and Takeda holds marketing authorization for the U.S. market. Brintellix® is a trademark of H. Lundbeck A/S and is used under license by Takeda Pharmaceuticals America.
Disease: major depression
Therapeutic area: CNS diseases - Mental diseases
Country: China, South Korea, Taiwan,Thailand
Trial
details: The objective of this 8 week study was to compare efficacy and tolerability of vortioxetine 10mg/day and venlafaxine XR 150mg/day in patients with Major Depressive Disorder from four Asian countries, China, South Korea, Taiwan and Thailand. A total of 437 adult patients with a MADRS total score ≥26 were treated (211 vortioxetine, 226 venlafaxine).
Latest
news: * On June 26, 2014, Lundbeck announced results of the SOLUTION trial conducted in Asian patients suffering from Major Depressive Disorder (MDD), more commonly referred to as depression. In this head-to-head study, Brintellix® (vortioxetine) was at least as efficacious as venlafaxine on the primary efficacy endpoint was better tolerated than venlafaxine. The data have been presented at the Congress of the International College of Neuropsychopharmacology (CINP). The study demonstrated that, after 8 weeks of treatment, Brintellix-treated patients (n=209) achieved substantial reductions (improvements) of depressive symptoms: -19.4 points on the Montgomery–Åsberg Depression Rating Scale (abbreviated MADRS) total score. The MADRS is one of the most commonly-used rating scales which psychiatrists use to measure the severity of depressive symptoms in patients suffering from depression. The objective of this 8 week study was to compare efficacy and tolerability of vortioxetine 10mg/day and venlafaxine XR 150mg/day in patients with Major Depressive Disorder from four Asian countries, China, South Korea, Taiwan and Thailand. Non-inferiority was established with a mean difference to venlafaxine of -1.20 points in favor of Brintellix (mean change from baseline in MADRS total score at Week 8, with 95% CI: -3.03 to -0.63). Brintellix and venlafaxine demonstrated similar improvements on the pre-defined secondary end-points, the Hamilton Anxiety rating scale (HAM-A), the Sheehan Disability Scale (SDS) total scores, the Clinical Global Impression (CGI) scale and the Quality of life enjoyment and satisfaction questionnaire (Q-LES-Q) scores, as well as on response and remission rates. Fewer Brintellix® than venlafaxine patients withdrew for any reason (18.0% versus 27.4%) or for adverse events (6.6% vs 13.7%). The most frequent AEs for vortioxetine were nausea, dizziness, dry mouth, and decreased appetite. The FDA approved Brintellix® on September 30, 2013 for the treatment of Major Depressive Disorder in adults. Brintellix was also approved in December 2013 by the European Commission for the treatment of adults with Major Depressive Episode commonly referred to as depression. More recently, the Australian Therapeutic Goods Administration (TGA) approved Brintellix® for the treatment of Major Depressive Disorders in April 2014.
