FDA Approves New Drug to Treat Major Depressive Disorder

Published Thursday, October 3, 2013

On September 30, the U.S. Food and Drug Administration approved Brintellix (vortioxetine) to treat adults with major depressive disorder (MDD). Six clinical studies in which adults with MDD were randomly assigned to receive Brintellix or placebo demonstrated that Brintellix is effective in treating depression, according to the FDA press release. An additional study showed Brintellix decreased the likelihood of participants becoming depressed again after treatment of their MDD episode. Brintellix is co-marketed by Takeda Pharmaceuticals and Lundbeck, both based in Deerfield, Ill.

Studies were conducted in the United States and other countries, and included more than 4,700 patients aged 18 to 88 years. The clinical trial program included six positive 6-8 week short-term studies, one of which was a dedicated study in the elderly. Takeda and Lundbeck report that the primary efficacy measure was the mean change from baseline to endpoint in the Hamilton Depression Scale (HAMD-24) total score in two short-term studies, including the elderly study, and the Montgomery-Asberg Depression Rating Scale (MADRS) total score in the other studies. The most common side effects reported by participants taking Brintellix in clinical trials included nausea, constipation and vomiting.

A joint press release from Takeda and Lundbeck states that Brintellix is expected to be available to patients by the end of the year.

Brintellix and other antidepressant drugs have a Boxed Warning and a Medication Guide alerting patients and health care professionals that antidepressants can increase the risk of suicidal thoughts and behavior in children, adolescents and young adults ages 18 to 24 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 ages 65 and older appear to have a reduced risk. The FDA advises that patients starting antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior.

For more information see the FDA press release at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm370416.htm and the Takeda and Lundbeck press release at www.lundbeck.com/upload/us/files/pdf/2013_Releases/BrintellixApprovalRelease.pdf.