The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that substantial evidence had been presented to support the efficacy of vortioxetine (Brintellix, Takeda/Lundbeck) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). The committee also discussed whether cognitive dysfunction in MDD represents an appropriate target for drug development.
The panel’s input will be considered by the agency in its review of the vortioxetine supplemental new drug application (sNDA), which was accepted for review in August 2015. The FDA is expected to make its approval decision by March 28, 2016. Vortioxetine was approved for the treatment of MDD in adults in September 2013.
The FDA’s advisory panel reviewed data from the FOCUS and CONNECT studies, which were designed to assess the effect of vortioxetine (10 or 20 mg/day) on certain aspects of cognitive dysfunction in adult patients (18 to 65 years of age) with MDD. These eight-week, randomized, double-blind, placebo-controlled studies used the Digit Symbol Substitution Test, a neuropsychological evaluation of cognitive performance.
Depression can involve a combination of symptoms, including cognitive dysfunction. According to a three-year prospective study of people treated for depression, cognitive symptoms (defined as a diminished ability to think or concentrate and/or indecisiveness) were reported 94% of the time during acute major depressive episodes and 44% of the time during remission.
Source: Lundbeck; February 4, 2016.