US label of Trintellix is expanded to refer to improvement in treatment emergent sexual dysfunction in depressed patients . Lundbeck + Takeda

H. Lundbeck A/S and its partner Takeda Pharmaceuticals USA, Inc., can once again expand the Clinical Trials section of the U.S. label of their antidepressant Trintellix (vortioxetine) as the FDA has approved a supplemental new drug application for the medicine. Trintellix is a prescription medicine approved for the treatment of adults with Major Depressive Disorder (MDD), also known as depression.

A common issue when treating MDD is that some medications can have a negative effect on sexual function, called treatment emergent sexual dysfunction (TESD). TESD can affect any aspect of the sexual response cycle including desire, arousal and orgasm.

The U.S. labeling of Trintellix now includes data from a head-to-head clinical study that demonstrates Trintellix is superior to the commonly-used selective serotonin reuptake inhibitor (SSRI) Lexapro (escitalopram) in improving SSRI-induced sexual dysfunction in adults with MDD. In this study, patients with well-treated depression who were experiencing SSRI-induced sexual dysfunction while taking paroxetine, sertraline or citalopram were switched to Trintellix or escitalopram. Switching to Trintellix led to improvement of TESD.