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FDA Accepts Supplemental NDA for Vortioxetine (Brintellix) for Patients With Major Depressive Disorder

Agency action expected by end of March 2016

The FDA has accepted a supplemental new drug application (sNDA) for review to add clinical data regarding the effect of vortioxetine (Brintellix, Takeda/Lundbeck) on certain aspects of cognitive function in adults with major depressive disorder (MDD) to the current product label. Vortioxetine is approved in the U.S. for the treatment of MDD in adults. The FDA is expected to take action on the new filing by March 28, 2016.

Depression is characterized by a range of symptoms, including cognitive ones. Common cognitive complaints include difficulty concentrating, indecisiveness, trouble thinking, and forgetfulness.According to a 3-year prospective study of people treated for depression, cognitive symptoms (defined as a diminished ability to think or to concentrate and/or indecisiveness) were reported 94% of the time during major depressive episodes and 44% of the time between major depressive episodes (or during periods of partial remission).

The new sNDA is primarily based on data from the FOCUS and CONNECT trials, which were specifically designed to assess the effect of vortioxetine (10 or 20 mg/day) on certain aspects of cognitive function in adult patients with MDD. Both of these 8-week, randomized, double-blind, placebo-controlled studies used the digit symbol substitution test (DSST) to evaluate neuropsychological status. The DSST performance measurement involves executive function, processing speed, and attention.

If approved by the FDA, vortioxetine would be the first treatment for MDD to include clinical trial data showing an effect on certain aspects of cognitive function in the U.S. label.

The FDA approved vortioxetine for the treatment of MDD in adults in September 2013.

The mechanism of the antidepressant effect of vortioxetine is not fully understood. The drug inhibits serotonin (5-HT) reuptake, and that is believed to be its mechanism of action. Vortioxetine is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors, and an antagonist at 5-HT3, 5-HT1D, and 5-HT7 receptors. The contribution of each of these activities to the antidepressant effect of vortioxetine has not been established.

The most commonly observed adverse events in MDD patients treated with vortioxetine in 6-week or 8-week, placebo-controlled studies included nausea, constipation, and vomiting. Overall, 5% to 8% of the patients who received vortioxetine (5 to 20 mg/day) in short-term trials discontinued treatment because of an adverse event, the most common being nausea, compared with 4% of placebo-treated patients in these studies. Vortioxetine and other antidepressants may cause serious adverse events.

Source: Takeda Pharmaceuticals U.S.A.; August 10, 2015.


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