Takeda Pharmaceutical Company Limited — Trintellix FDA Review (NDA204447, SUPPL 17, 2018)
Takeda Pharmaceutical Company Limited · 2018 · FDA Review (openFDA) · company profile →
Report summary
Takeda Pharmaceutical Company Limited received FDA approval on October 19, 2018, for a supplemental New Drug Application (sNDA) for Trintellix (vortioxetine), updating its prescribing information to include data on treatment-emergent sexual dysfunction (TESD). Trintellix, indicated for major depressive disorder (MDD) in adults (5-20 mg/day), demonstrated efficacy in improving MDD symptoms and cognitive function. Crucially, two studies (318 and 4001) showed vortioxetine's superiority over escitalopram and paroxetine, respectively, in reducing TESD while maintaining antidepressant efficacy. The drug's safety profile, including common adverse reactions like nausea, remains consistent with its approved label, with no new safety concerns identified. This approval highlights Trintellix's potential benefits in addressing a significant side effect of antidepressant treatment.
Key findings — cited to the page
| Recommended starting dose | 10 mg | TRINTELLIX · p.9 |
| Dose for patients who do not tolerate higher doses | 5 mg/day | TRINTELLIX · p.9 |
| Labeling Update | clinically relevant information on treatment-emergent sexual dysfunction | Trintellix (vortioxetine) · p.4 |
| Indication | TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults | TRINTELLIX · p.9 |
| Dose increase | 20 mg/day | TRINTELLIX · p.9 |
| PDUFA target date for labeling communication | September 21, 2018 | Trintellix (vortioxetine) sNDA · Global · p.155 |
| Labeling resubmission request date | September 27, 2018 | Trintellix (vortioxetine) sNDA · Global · p.155 |
| PDUFA user fee goal date | October 21, 2018 | Trintellix (vortioxetine) sNDA · Global · p.167 |
| Approval Date | October 19, 2018 | TRINTELLIX · p.1 |
| Indication | TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) | TRINTELLIX · p.1 |
| sNDA submission date | December 21, 2017 | Trintellix (vortioxetine) sNDA · Global · p.155 |
| Dose reduction for discontinuation (15 mg/day or 20 mg/day) | 10 mg/day for one week | TRINTELLIX · p.9 |
Source: Takeda Pharmaceutical Company Limited ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →