The Food and Drug Administration has approved brexpiprazole (Rexulti) tablets for schizophrenia in adults and as an add-on therapy for adults who are treated with antidepressants for major depressive disorder.
The effectiveness of brexpiprazole for treating schizophrenia was evaluated in more than 1,300 patients in two 6-week clinical trials, and the drug was shown to reduce the occurrence of symptoms, compared with placebo. Effectiveness of brexpiprazole as add-on therapy in the setting of major depressive disorder was evaluated in 1,046 patients in two 6-week trials, and the subjects, whose depression was inadequately treated with antidepressants alone, reported fewer symptoms of depression with brexpiprazole, compared with placebo.
“Schizophrenia and major depressive disorder can be disabling and can greatly disrupt day-to-day activities. Medications affect everyone differently, so it is important to have a variety of treatment options available for patients with mental illness,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in a July 13 statement announcing the July 10 approval.
Brexpiprazole, like other drugs used to treat schizophrenia, will carry a boxed warning alerting health care professionals about an increased risk of death with off-label use for treating behavioral problems in older persons with dementia-related psychosis. Also in the boxed warning is an alert of an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
The drug is manufactured by Otsuka under the trade name Rexulti.