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FDA NEWS RELEASE

For Immediate Release: Sept. 30, 2013
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves new drug to treat major depressive disorder

The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.

Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mood changes and other symptoms that interfere with a person's ability to work, sleep, study, eat and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime, although some may experience a single occurrence.

Other signs and symptoms of MDD include loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. Not all people with MDD experience the same symptoms.

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

Six clinical studies in which adults with MDD were randomly assigned to receive Brintellix or placebo demonstrated that Brintellix is effective in treating depression. An additional study showed Brintellix decreased the likelihood of participants becoming depressed again after treatment of their MDD episode. These studies were conducted in the United States and other countries.

The most common side effects reported by participants taking Brintellix in clinical trials included nausea, constipation and vomiting. 

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

Brintellix and other antidepressant drugs have a Boxed Warning and a Medication Guide alerting patients and healthcare 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. Patients starting antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior.

Brintellix is co-marketed by Takeda Pharmaceuticals and Lundbeck, both based in Deerfield, Ill.

For more information:

FDA: Antidepressant Use in Children, Adolescents, and Adults

FDA: Approved Drugs: Questions and Answers

FDA: Drug Innovation 

National Institute of Mental Health: Depression

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 10/10/2013
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