FDA Accepts a sNDA for Review of Brintellix (Vortioxetine) Trial Data that Assessed Cognitive Function in Patients with MDD

H. Lundbeck A/S and Takeda Pharmaceutical Company Limited have announced the 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 dysfunction in adults with Major Depressive Disorder (MDD) to the current product label. Brintellix is currently approved and available in the US for the treatment of MDD in adults. The FDA is expected to take action on this filing by 28 March 2016.

"Cognitive symptoms are often present in patients suffering from MDD and reducing these symptoms can be challenging," explains John Zajecka, Associate Professor of Psychiatry, Rush University Medical Center, in Chicago. "Many patients continue to experience certain cognitive and other symptoms even after improvement in their MDD."

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.

The FDA approved Brintellix on 30 September 2013 for the treatment of MDD in adults. Brintellix is furthermore approved in 55 countries (including Europe, Canada, Chile, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore and South Africa). It is available in approximately 30 countries to date.