FDA approves Rexulti for schizophrenia, major depressive disorder in adults

The FDA recently approved Rexulti tablets to treat adults with schizophrenia and as an add-on to antidepressant medications for adults with major depressive disorder.

Researchers assessed the efficacy of Rexulti (brexpiprazole, Otsuka Pharmaceuticals) to treat schizophrenia among 1,310 participants in two 6-week clinical trials.

Results indicated brexpiprazole reduced the occurrence of symptoms of schizophrenia compared with placebo, according to an FDA press release.

Brexpiprazole was evaluated as an add-on treatment for major depressive disorder in two 6-week trials comparing brexpiprazole plus an antidepressant and placebo plus an antidepressant among 1,046 participants who were not adequately treated with a single antidepressant.

Study participants who received brexpiprazole reported fewer symptoms of depression than those who received placebo.

The most common adverse effects of brexpiprazole were weight gain and an inner sense of restlessness, according to results from the clinical trials.

Brexpiprazole has a boxed warning about an increased risk for suicidal thinking and behavior among children, adolescents and young adults taking antidepressants. The boxed warning also cautions that off-label use of brexpiprazole to treat behavioral problems among older individuals with dementia-related psychosis is associated with an increased risk for death.

No drug in this class is approved to treat dementia-related psychosis, according to the FDA.

“Schizophrenia and major depressive disorder can be disabling and can greatly disrupt day-to-day activities,” Mitchell Mathis, MD, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Medications affect everyone differently so it is important to have a variety of treatment options available for patients with mental illnesses.”