FDA Approves New Treatment for Schizophrenia and Depression

By Kelly Young

Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD

The FDA has approved brexpiprazole (Rexulti) to treat schizophrenia and as an adjunctive treatment to antidepressants for patients with major depressive disorder.

Approval was based on the results of clinical trials involving over 1300 patients with schizophrenia and 1000 patients with depression that was not well controlled with antidepressants. Symptoms of schizophrenia and depression were improved in patients randomized to brexipiprazole, compared with those receiving placebo.

Like other schizophrenia drugs, brexipiprazole will carry a boxed warning about the drug's elevated mortality risk when used off-label to treat behavioral issues in older adults who have dementia-related psychosis. The boxed warning will also describe an elevated risk for suicidality in children, adolescents, and young adults who take antidepressants. Younger patients should be monitored for suicidality.

Weight gain and restlessness are common side effects.