New Antidepressant Approved by the FDA: Brintellix

First Posted: Oct 01, 2013 11:32 AM EDT

Monday the Food and Drug Administration approved a new antidepressant medication commercially named Brintellix. It works as a selective serotonin reuptake inhibitor or SSRI for a depression treatment.

The drug received the agency's approval without deliberation by a science advisory panel, a public review of an investigative drug's safety and effectiveness. The FDA announced that the new medication was found "effective in treating depression" in six clinical trials compared to outcomes in subjects taking the drug against those of subjects who had received a placebo.

They also cited a clinical trial that was found among those taking Brintellix as a decreased likelihood of becoming clinically depressed following successful treatment for earlier episodes.

Similar to other antidepressants, the medication Brintellix carries a boxed warning alerting patients and physicians that taking the medication can increase suicidal thoughts and behavior in children, adolescents and young adults between 18 and 24.

Brintellix is co-marketed by the Japanese firm Takeda Pharmaceuticals and the Danish pharmaceutical company Lundbeck.

Reuters reports that the product will treat major depressive disorders in adults, which is characterized by mood changes that may interfere with a person's ability to carry out day-to-day activities. Various symptoms may include increased fatigue and feelings of guilt or worthlessness.

"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, via the FDA. "Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression."

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