FDA Approves Vortioxetine for Major Depression

Caroline Cassels


September 30, 2013

Vortioxetine (Brintellix, Takeda Pharmaceuticals and Lundbeck), an investigational multimodal antidepressant thought to work through a combination of 2 pharmacologic modes of action ― serotonin (5-HT) receptor activity modulation and 5-HT reuptake inhibition ― has been approved by the US Food and Drug Adminstration (FDA) for major depressive disorder in adults.

The approval was based on safety and efficacy data from 6 multicenter, randomized, double-blind, parallel group trials of adult patients testing doses of vortioxetine ranging from 5 to 20 mg/day compared with placebo.

Some of these data from 4 trials were recently presented at the American Psychiatric Association's 2013 Annual Meeting and reported by Medscape Medical News at that time. In those studies, 3 of the 4 met the primary efficacy endpoint, as measured by the change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 8.

The 20-mg dose had the most consistent effect in relation to placebo.

One of the studies did not meet the primary endpoint. However, the manufacturer noted that all of the trials provided additional information regarding the drug's safety profile.

The most common side effects, which lead researcher Madhukar Trivedi, MD, told Medscape Medical News was "not outside the realm of what is normally seen with antidepressants," included nausea, headache, diarrhea, dizziness, constipation, vomiting, fatigue, and viral upper respiratory infection.

"Major depressive disorder can be disabling and can keep a person from functioning normally. Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression," Mitchell Mathis, MD, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a release.

Like other antidepressant medications, Brintellix has an FDA boxed warning and a medication guide alerting patients and healthcare professionals that antidepressants can increase the risk for suicidal thought and behavior in children, adolescents, and young adults aged 18 to 24 years during initial treatment.

Brintellix will be available in 5-mg, 10-mg, 15-mg, and 20-mg tablets.


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