No improved antidepressant effect of vortioxetine, relative to placebo, was observed in several studies, and in studies showing a stastically significant difference between groups, the added effect of vortioxetine compared with placebo was modest. Some studies have compared vortioxetine with venlafaxine and duloxetine, but the studies were not designed to show any differences and bias cannot be excluded. No formal statistical comparison has been performed, but both venlafaxine and duloxetine were numerically superior to vortioxetine. Robust long-term data are not available.
Nausea is a very common adverse event. Sexual dysfunction was less frequent for 10 mg vortioxetine than for duloxetine and venlafaxine treatment. Anticholinergic events, such as dry mouth, constipation and hyperhidrosis, were also less frequent. In the opinion of IRF, the impact on the risk of suicidal behaviour and the extent of any discontinuation syndrome have not been adequately described.
The treatment price of vortioxetine is very high compared with the alternatives, e.g. citalopram, escitalopram and venlafaxine. Conditional reimbursement is granted for vortioxetine.
It is IRF’s overall assessment that vortioxetine is not first-line treatment for depression. Vortioxetine may be used in patients with no suicidal thoughts who have experienced unacceptable adverse events from treatment with various antidepressants.
Brintellix was marketed on 15 September 2014. Conditional reimbursement is granted for vortioxetine to treat depression, where treatment with an antidepressant with general unconditional reimbursement has proven inadequate or is not tolerated.