FDA approves Brintellix for major depressive disorder
FDA Approves Brintellix for Major Depressive Disorder
HealthDay News -- The FDA has approved vortioxetine (Brintellix) to treat adults with major depressive disorder.
“Major depressive disorder can be disabling and can keep a person from functioning normally,” said Mitchell Mathis, MD, of 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.”
Results from six clinical studies indicated vortioxetine is effective in treating depression, and results of an additional trail showed it was effective at preventing future episodes of major depressive order, the FDA said in a press release. The most common side effects observed included nausea, constipation and vomiting.
Vortioxetine will be available in 5 mg, 10 mg and 20 mg oral tablets. It will carry a boxed label warning about the increased risk for suicidal thoughts among some users, especially among children, adolescents and adults aged 18 to 24.
Clinicians should carefully monitor patients on antidepressant therapy or worsening of their depression and the emergence of suicidal thoughts and behavior, especially during initial treatment, the FDA advised.
Vortioxetine is marketed by Takeda Pharmaceuticals and Lundbeck, both based in Deerfield, Ill.