FDA Approves New Antidepressant
WebMD News Archive
The drug Brintellix has been approved to treat depression, the U.S. Food and Drug Administration announced Monday.
"Major depressive disorder can be disabling and can keep a person from functioning normally," Dr. Mitchell Mathis, acting director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, said in a news release. "Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression."
The approval was based on the results of six clinical trials where Brintellix (vortioxetine) was pitted against a placebo medication, the agency said. FDA officials also looked at a seventh study that found the medication lowered the chances of a recurrence after patients were treated successfully for an initial bout of depression.
Side effects seen during the trials included nausea, constipation and vomiting. Like other antidepressants already on the market, Brintellix will carry a "black box" warning that states these medications can raise the risk of suicidal thoughts and behavior in adolescents and young adults who take them, the FDA said.
The hallmarks of depression include loss of interest in daily activities, weight changes, insomnia or the opposite, restlessness, slowed thinking or impaired concentration and suicidal thoughts and behaviors.
Marketed by Takeda Pharmaceuticals and Lundbeck, both based in Deerfield, Ill., Brintellix will be sold in 5 milligram (mg), 10 mg, 15 mg and 20 mg tablets. Doctors should watch any patients starting on antidepressants for a worsening of symptoms, according to the FDA.