NeuroCog Trials welcomes the outcome of the FDA Psychopharmacologic Drug Advisory Committee meeting that cognitive dysfunction in Major Depressive Disorder (MDD) represents an appropriate drug development target.
The issue was discussed at the meeting on February 3rd as Takeda and Lundbeck presented data from their vortioxetine (BRINTELLIX®) development program, with the panel voting 8-2 that substantial evidence had been presented to support the claim of effectiveness. The program included two pivotal trials, FOCUS and CONNECT, with cognitive dysfunction as the primary outcome alongside additional prespecified endpoints for depression, cognition and function.
The CONNECT study included the UPSA (University of California, San Diego Performance-based Skills Assessment) as a performance-based functional assessment, which was supported operationally by NeuroCog Trials. The UPSA differentiated vortioxetine from placebo, whereas duloxetine did not. The UPSA data provide supportive evidence that the reduction of cognitive dysfunction with vortioxetine may translate into read world gains for patients with MDD.
Data from the CONNECT study were recently published in Neuropsychopharmacology in collaboration with Takeda and Lundbeck Pharmaceutical Companies and Rush University Medical Center:
View press release from Takeda Pharmaceutical Company Limited and H. Lundbeck A/S: