TESD can affect any aspect of the sexual response cycle including desire, arousal and orgasm. Changing to a medication with potentially fewer sexual side effects, while not losing progress in treating depression, provides an important option for patients with depression.” “We designed the study to specifically look at these troublesome side effects. Anita Clayton, Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine. “Sexual dysfunction is one of the most common and bothersome side effects patients with depression struggle with when prescribed an SSRI,” said lead study investigator, Dr.

These data build upon the voluntary and prospective reports of sexual dysfunction with TRINTELLIX in clinical trials. This is the first time an antidepressant has included data of this type in its labeling. In the study, patients with well-treated depression who were experiencing TESD while taking an SSRI (paroxetine, sertraline or citalopram) were switched to TRINTELLIX or escitalopram. prescribing information now includes head-to-head clinical study data that demonstrated superiority to a commonly-used selective serotonin reuptake inhibitor (SSRI), Lexapro® (escitalopram) in improving treatment-emergent sexual dysfunction (TESD). Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for TRINTELLIX® (vortioxetine), a prescription medication used for adults with major depressive disorder (MDD), also known as depression. (“Takeda”) and Lundbeck today announced that the U.S. This is the second time this year the FDA has approved a TRINTELLIX labeling updateĭeerfield, IL, Octo– Takeda Pharmaceuticals U.S.A., Inc.TRINTELLIX is the first antidepressant to include head-to-head data in its labeling that showed improvement in treatment-emergent sexual dysfunction in patients with MDD who switched from certain SSRI treatments.

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