Brintellix
Psychiatry· 986 cited findings· 2 source documents
Company: H. Lundbeck A/S
What the regulatory reviews say
Brintellix (vortioxetine) is indicated for the treatment of major depressive episodes in adults. The Marketing Authorisation Application was submitted on 24 August 2012, with EMA/CHMP eligibility agreed on 15 March 2012. A CHMP positive opinion was issued between 21-24 October 2013, and US Marketing Authorisation was granted on 30th September 2013. The proposed maximum daily dose is 20 mg, with a minimum daily dose of 5 mg. Recommended treatment duration after symptom resolution is 6 months.
Efficacy findings include a MADRS total score change from baseline (meta-analysis) of -2.3 to -4.6 points. The MADRS Response Rate was 6.35% and the Remission Rate was 12.13%. In animal models, vortioxetine demonstrated efficacy in various tests, such as a MED of 5 mg/kg/day p.o. in novelty-induced suppression of feeding in mice and a dose of 1 mg/kg p.o. in the social interaction test in rats.
Safety data indicates an incidence of nausea of 27% and constipation of 4% in patients aged <65 years in the Vortioxetine 20 mg group. Vortioxetine Cmax at a 20 mg dose in healthy volunteers was 33 ng/mL. The IC50 for hERG current was 2538 fold higher relative to human unbound plasma exposure, and for SCN5A sodium ion channels, it was 715 fold higher.
Key figures — cited to the source page
| MADRS total score change from baseline (meta-analysis) | -4.6 | H. Lundbeck A/S — Brintellix EMA EPAR public assessment repo, p.101 |
| MADRS Response Rate | 6.35 | H. Lundbeck A/S — Brintellix EMA EPAR public assessment repo, p.99 |
| Incidence of nausea (Vortioxetine 20 mg group, <65 years) | 27 | H. Lundbeck A/S — Brintellix EMA EPAR public assessment repo, p.156 |
| Vortioxetine Cmax (20 mg dose, healthy volunteers) | 33 | H. Lundbeck A/S — Brintellix EMA EPAR public assessment repo, p.18 |
| IC50 for hERG current relative to human unbound plasma exposure | 2538 | H. Lundbeck A/S — Brintellix EMA EPAR public assessment repo, p.18 |
| Marketing Authorisation Application submission date | 24 August 2012 | H. Lundbeck A/S — Brintellix EMA EPAR public assessment repo, p.6 |
| US Marketing Authorisation date | 30th September 2013 | H. Lundbeck A/S — Brintellix EMA EPAR public assessment repo, p.6 |
| Vortioxetine proposed maximum daily dose | 20 | H. Lundbeck A/S — Brintellix EMA EPAR public assessment repo, p.9 |
Source documents
Explore the full evidence
All 986 cited findings for Brintellix — 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.