Takeda Presents New Trial Data For Brintellix In MDD
Takeda Pharmaceutical and H. Lundbeck reported new results from the CONNECT trial investigating efficacy of Brintellix 10-20 mg/d in measures of cognitive performance in adults with major depressive disorder (MDD).
Brintellix (vortioxetine) is an antidepressant discovered by Lundbeck researchers in Copenhagen, Denmark and jointly developed with Takeda. The drug’s mechanism of action and antidepressant effect is not fully understood. Brintellix is a serotonin (5-HT) reuptake inhibitor and an agonist at 5-HT1A receptors. It is also a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The U.S. Food and Drug Administration (FDA) granted approval to Brintellix in September 2013 for the treatment of MDD in adults. Takeda is currently responsible for the drug’s New Drug Application (NDA) in the U.S.
In the study, Brintellix demonstrated superiority to placebo based on the objective neuropsychological test (the Digit Symbol Substitution Test or DSST) associated with attention, executive function, and processing speed in adults with MDD. A pre-specified path analysis indicated that the drug’s effect was mainly a result of direct treatment instead of alleviation of overall depressive symptoms.
“Symptoms of impaired cognitive function, which include a diminished ability to think, concentrate or make decisions, can be common for people with MDD, and this area is in need of further investigation. These study results are encouraging and while further investigation is warranted, they are similar to previous published clinical trial data for Brintellix on aspects of cognitive function in patients with MDD,” said John Zajecka, study investigator and Associate Professor of Psychiatry at Rush University Medical Center.
The exact cause of major depressive disorder is not fully known but research suggests that multiple serotonin receptors may influence many biologic and neurologic processes in the disease.
The company said it will present the data as a late-breaker poster at the 29th International College of Neuropsychopharmacology (CINP) World Congress in Vancouver, Canada.