Brintellix by H. Lundbeck A/S and Takeda Pharmaceuticals America, Inc

AUGUST 07, 2014
Monica Holmberg, PharmD, BCPS
The FDA has approved H. Lundbeck A/S and Takeda Pharmaceuticals America, Inc’s Brintellix (vortioxetine) for the treatment of major depressive disorder (MDD) in adults. The approval carries a boxed warning regarding an increased risk for suicidal thoughts and behaviors.1 In 2010, clinical depression was the second-leading cause of global disability. It is estimated that 30 million Americans have been affected by MDD during their lifetime.2

Pharmacology and Pharmacokinetics
Brintellix’s mechanism of action is not fully understood, but it is believed to be related to its inhibition of the reuptake of serotonin (5-HT). It is an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors, and an antagonist at 5-HT3, 5-HT1D, and 5-HT7 receptors.1,2

When administered once daily, Brintellix displays linear and doseproportional pharmacokinetics. The mean terminal half-life is approximately 66 hours, and steady-state plasma concentrations are usually achieved within 2 weeks of therapy.1

Dosage and Administration
Treatment with Brintellix should be initiated as 10 mg orally once daily and increased to 20 mg daily when tolerated. In patients unable to tolerate higher doses, the dosage may be decreased to 5 mg daily. Treatment should be sustained for several months or longer. Treatment may be discontinued abruptly; however, decreasing the dosage to 10 mg daily for 1 week prior to cessation may minimize adverse reaction’s. Known CYP2D6 poor metabolizers should not use more than 10 mg daily. Brintellix may be taken without regard to food.1

Clinical Trials
Brintellix was evaluated in 6 randomized, double-blind, placebocontrolled, fixed-dose studies of 6 to 8 weeks’ duration. Each study demonstrated that treatment with Brintellix was superior to treatment with placebo.

One study evaluated the role of Brintellix as maintenance treatment in adult inpatients and outpatients with MDD. All patients received Brintellix until week 12, at which point patients in remission were randomized to either continue Brintellix or placebo for 24 to 64 weeks. Patients using Brintellix experienced a statistically significantly longer time to recurrence of depressive episodes than those using placebo.1,3

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