Takeda announced that the Food and Drug Administration (FDA) has approved a labeling update for Trintellix (vortioxetine) to include new head-to-head clinical data comparing it to Lexapro (escitalopram; Allergan) for improving treatment-emergent sexual dysfunction (TESD).
Trintellix, a serotonergic agonist and antagonist, is currently approved to treat adults with major depressive disorder (MDD). Lexapro, a selective serotonin reuptake inhibitor (SSRI), is indicated for the treatment of generalized anxiety disorder and MDD.
In the 8-week, randomized, double-blind study, patients with depression who had TESD (N=447) while taking an SSRI (eg, paroxetine, sertraline or citalopram) were switched to Trintellix or escitalopram, due to SSRI-induced sexual dysfunction. Results showed treatment with Trintellix led to statistically significant improvement vs escitalopram from baseline to week 8 as measured by mean Change in Sexual Functioning Questionnaire short form (CSFQ-14) Total Score (8.8 vs 6.6; P =.013). In addition, both study drugs maintained prior improvement in depression based on overall score on standardized depression rating scale.
“We designed the study to specifically look at these troublesome side effects. 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,” stated Dr. Anita Clayton, Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, and lead investigator of the study.
For more information visit Trintellix.com.