Rexulti approved for schizophrenia, MDD

FDA approved brexpiprazole (Rexulti) for schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).

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

Rexulti’s manufacturer, Tokyo-based Otsuka Pharmaceutical Company Ltd., evaluated the effectiveness of the drug in treating schizophrenia in 1,310 participants in two 6-week clinical trials. Rexulti was shown to reduce the occurrence of symptoms of schizophrenia compared to placebo (inactive tablet).

In addition, the effectiveness of Rexulti as an add-on treatment for MDD was evaluated in two 6-week trials that compared Rexulti plus an antidepressant to placebo plus an antidepressant in 1,046 participants for whom an antidepressant alone did not adequately treat their symptoms. The participants taking Rexulti reported fewer symptoms of depression than those taking the placebo. 

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The most common side effects reported by participants taking Rexulti in clinical trials included weight gain and an inner sense of restlessness, such as feeling the need to move.

The Boxed Warning on Rexulti and other drugs in this class alert health care professionals and patients to an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors.

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The Boxed Warning also alerts healthcare professionals about an increased risk of death associated with the off-label use of drugs in this class to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

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