Takeda Pharmaceutical Company Limited and H. Lundbeck A/S announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD) to the current product label. Brintellix is currently approved and available in the U.S. for the treatment of MDD in adults. The FDA is expected to take action on this filing by March 28, 2016.
Depression includes a range of symptoms including cognitive ones. The cognitive symptoms of depression may go unrecognized by both healthcare providers and patients. Common cognitive complaints include difficulty concentrating, indecisiveness, trouble thinking and forgetfulness. These symptoms are common and many of them often persist between major depressive episodes According to a three-year prospective study of people treated for depression, cognitive symptoms (defined as diminished ability to think or concentrate and/or indecisiveness) were reported 94 percent of the time during major depressive episodes and 44 percent of the time between major depressive episodes (or during periods of partial remission).
The sNDA is primarily based on the FOCUS and CONNECT studies, which were specifically designed to assess the effect of Brintellix on certain aspects of cognitive function in adult patients with MDD utilizing objective measures of cognitive function. These two 8-week, randomized, double-blind, placebo-controlled studies of Brintellix 10 and 20 mg/day used a well-established neuropsychological test (the Digit Symbol Substitution Test or DSST). The DSST performance measurement involves executive function, processing speed and attention.
