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Home » Drug Information » FDA Approved Drugs » 2013
Medical Areas: Psychiatry/Psychology

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Brintellix (vortioxetine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Takeda Pharmaceuticals USA
Approval Status: Approved October 2013
Treatment Area: Major Depressive Disorder

General Information

Brintellix (vortioxetine) is a serotonin modulator and stimulator. It belongs to a psychotropic class of chemical compunds known as bis-aryl-sulphanyl amines.

Brintellix is specifically indicated for Major Depressive Disorder.

Brintellix is supplied as a tablet for oral administration. The recommended starting dose is 10 mg administered orally once daily without regard to meals. The dose should then be increased to 20 mg/day, as tolerated.

Clinical Results

FDA Approval
The FDA approval of Brintellix was based on six 6 to 8 week randomized, double-blind, placebo-controlled, fixed-dose studies (including one study in the elderly) and one maintenance study in adult inpatients and outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD.
Adults (aged 18 years to 75 years)
The efficacy of Brintellix in subjects aged 18 years to 75 years was demonstrated in five 6 to 8 week, placebo-controlled studies. In these studies, subjects were randomized to Brintellix 5 mg, 10 mg, 15 mg or 20 mg or placebo once daily. For subjects who were randomized to Brintellix 15 mg/day or 20 mg/day, the final doses were titrated up from 10 mg/day after the first week. The primary efficacy measures were the Hamilton Depression Scale (HAMD-24) total score in Study 2 and the Montgomery-Asberg Depression Rating Scale (MADRS) total score in all other studies. In each of these studies, at least one dose group of Brintellix was superior to placebo in improvement of depressive symptoms as measured by mean change from baseline to endpoint visit on the primary efficacy measurement.
Elderly
The efficacy of Brintellix for the treatment of MDD was also demonstrated in a randomized, double-blind, placebo-controlled, fixed-dose study of Brintellix in elderly subjects (aged 64 years to 88 years) with MDD. Subjects received Brintellix 5 mg or placebo. The primary endpoints were also reached in this population.
Maintenance Study
In a non-US maintenance study 639 subjects meeting DSM-IV-TR criteria for MDD received flexible doses of Brintellix (5 mg or 10 mg) once daily during an initial 12 week open-label treatment phase; the dose of Brintellix was fixed during Weeks 8 to 12. Three hundred ninety six (396) patients who were in remission (MADRS total score =10 at both Weeks 10 and 12) after open-label treatment were randomly assigned to continuation of a fixed dose of Brintellix at the final dose they responded to (about 75% of patients were on 10 mg/day) during the open-label phase or to placebo for 24 to 64 weeks. Approximately 61% of randomized patients satisfied remission criterion (MADRS total score =10) for at least 4 weeks (since Week 8), and 15% for at least 8 weeks (since Week 4). Patients on Brintellix experienced a statistically significantly longer time to have recurrence of depressive episodes than did patients on placebo.

Side Effects

Adverse reactions associated with the use of Brintellix may include, but are not limited to, the following:

  • nausea
  • constipation
  • vomiting

Mechanism of Action

The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism.

Literature References

Jain R, Mahableshwarkar AR, Jacobsen PL, Chen Y, Thase ME A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. The international journal of neuropsychopharmacology 2013 Mar;16(2):313-21

Additional Information

For additional information regarding Brintellix or Major Depressive Disorder, please visit the Brintellix web page.