US regulators have agreed to take a look at Lundbeck and Takeda’s supplemental New Drug Application for the antidepressant Brintellix, which seeks to add clinical data to the drug’s label on its effect on cognitive dysfunction in adults with Major Depressive Disorder. 

Brintellix (vortioxetine) is currently approved and available in the US for the treatment of MDD in adults, but the firms have now filed data from the FOCUS and CONNECT studies which show that it can improve certain aspects of cognitive dysfunction, such as processing speed and attention.

The cognitive symptoms of depression - diminished ability to think or concentrate and/or indecisiveness - may go unrecognised by both healthcare providers and patients, and yet they are extremely common and often persist between major depressive episodes, the firms note.

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

Brintellix inhibits serotonin (5-HT) reuptake and 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. Lundbeck says the drug “is considered to be the first and only compound with this combination of pharmacodynamic activity”, but its mechanism is not fully understood.

A decision from the US Food and Drug Administration on whether the new cognitive data can be added to the drug’s label is expected by March 28 next year.