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news.The US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 to recommend the use of Brintellix (vortioxetine) to treat certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD).
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The PDAC recommendation is based on the efficacy results from FOCUS and CONNECT studies, which were specifically designed to evaluate the effect of Brintellix on certain aspects of cognitive dysfunction in adult patients aged between 18 and 65 with MDD.
These two 8-week, randomized, double-blind, placebo-controlled studies of Brintellix 10 and 20 mg/day used a neuropsychological test.
Takeda Pharmaceutical CNS therapeutic area unit head Emiliangelo Ratti said: "Today’s positive recommendation underscores the role of addressing the medical need of patients who experience cognitive dysfunction in depression.
"Common cognitive symptoms include difficulty concentrating, indecisiveness and trouble thinking. Many of these symptoms are prevalent during major depressive episodes and can have an impact on depressed patients."
Brintellix was discovered by Lundbeck researchers and the clinical trial program in the US was conducted jointly by the two firms, while Takeda holds the new drug application for the US market.
Takeda said that Brintellix is an antidepressant used to treat depression with multiple symptoms, including cognitive dysfunction.
It is said to inhibit serotonin (5-HT) reuptake and works as 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.