FDA approves vortioxetine to treat major depressive disorder

FDA approved vortioxetine (Brintellix, Takeda Pharmaceuticals and Lundbeck) to treat adults with major depressive disorder (MDD) on September 30

Although the drug’s mechanism of action is not fully understood, Takeda noted, vortioxetine is an inhibitor of serotonin (5-HT) reuptake, which is considered its mechanism of action. The drug also 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, Takeda said.

“The FDA approval of Brintellix for the treatment of major depressive disorder offers individuals who are diagnosed with this debilitating condition another alternative antidepressant with a novel mechanism of action,” said Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “Brintellix may serve as another option for those who may have failed treatment with other antidepressants in the past.”

In the United States and other countries, 6 clinical studies enrolled adults with MDD who were randomly assigned to receive vortioxetine or placebo. The trials demonstrated positive results that vortioxetine is effective for the treatment of depression. In an additional study vortioxetine decreased the likelihood of recurrent depression in patients treated for their MDD episode.

Nausea, constipation, and vomiting were the most common side effects reported by participants taking vortioxetine in clinical trials.

Vortioxetine will be available in 5-mg, 10-mg, 15-mg and 20-mg tablets. It is expected to be available by the end of 2013.

A Boxed Warning and a Medication Guide is included with vortioxetine and other antidepressant drugs to alert patients and healthcare professionals that antidepressants can increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults aged 18 to 24 years during initial treatment. Studies show adults older than 24 years of age do not appear to have an increased risk of suicidal thoughts and behavior, while adults aged 65 and older appear to have a reduced risk. Patients starting antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior.