Trintellix (vortioxetine) Tablets

Psychiatry· 247 cited findings· 1 source document

Company: Takeda Pharmaceutical Company Limited →

What the regulatory reviews say

Trintellix (vortioxetine) Tablets received initial U.S. approval in 2013 for the treatment of major depressive disorder (MDD) in adults. A Supplemental New Drug Application (sNDA) was received on January 14, 2020, with a user fee goal date of November 14, 2020. The labeling was revised in November 2020.

Efficacy findings include changes from baseline in MADRS scores, with values such as -5.9, -5.7, -5.5, and -7.1. HAMD-24 change from baseline was observed at -4.1 and -4.9. DSST correct responses changed from baseline by 4.2 and 4.3. The CSFQ-14 total score showed a 2.2 point improvement from baseline. The primary endpoint of Study LuAA21004_402 was time in weeks from randomization to relapse of any mood event during the double-blind treatment period.

Safety information indicates an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. For patients over age 24, there was no increase in this risk, and a trend toward reduced risk was observed in patients aged 65 and older. The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were nausea, constipation, and vomiting. The incidence of mania/hypomania in premarketing clinical studies was <0.1%.

Key figures — cited to the source page

MADRS change from baseline	-7.1	Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.30
HAMD-24 change from baseline	-4.9	Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.30
DSST correct responses change from baseline	4.3	Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.32
CSFQ-14 total score change from baseline	2.2 point improvement	Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.34
Risk of suicidal thinking and behavior in children, adolescents, and young adults	Increased	Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.9
Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo)	nausea, constipation and vomiting	Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.9
Initial U.S. Approval	2013	Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.9
Indication	treatment of major depressive disorder (MDD) in adults	Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.9

Source documents

Takeda Pharmaceutical Company Limited — Trintellix FDA Review (NDA204447, SUPPL 20, 2020) (2020)

Explore the full evidence

All 247 cited findings for Trintellix (vortioxetine) Tablets — searchable, comparable and answerable in plain language — are in the Psychiatry research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.