Creating a free account will enable you to subscribe to our daily and weekly email newsletters, as well as customize your reading experience to show only the categories most relevant to you.
Signing up only take a few minutes, so why not give it a try and see what you've been missing out on.
The U.S. Food and Drug Administration has 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.
Article adapted by Medical News Today from original press release. Source:
Please use one of the following formats to cite this article in your essay, paper or report:
FDA. "FDA approves new drug to treat major depressive disorder." Medical News Today. MediLexicon, Intl., 4 Oct. 2013. Web.
12 Dec. 2013. <http://www.medicalnewstoday.com/releases/266993>
FDA. (2013, October 4). "FDA approves new drug to treat major depressive disorder." Medical News Today. Retrieved from
Please note: If no author information is provided, the source is cited instead.
If you write about specific medications, operations, or procedures please do not name healthcare professionals by name.
For any corrections of factual information, or to contact the our editorial team, please use our feedback form. Please send any medical news or health news press releases to:
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.
This page was printed from: http://www.medicalnewstoday.com/releases/266993.php
Visit www.medicalnewstoday.com for medical news and health news headlines posted throughout the day, every day.
© 2004-2013 All rights reserved. MNT (logo) is the registered trade mark of MediLexicon International Limited.