FDA Approves Rexulti for Schizophrenia, Depression

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FDA Approves Rexulti for Schizophrenia, Depression
FDA Approves Rexulti for Schizophrenia, Depression

MONDAY, July 13, 2015 (HealthDay News) -- Rexulti (brexpiprazole) has been approved by the U.S. Food and Drug Administration to treat schizophrenia, and as an add-on drug for major depressive disorder (MDD) when a first-line drug fails to effectively treat symptoms.

Clinical studies evaluating Rexulti for both schizophrenia and MDD involved more than 2,300 people. The most common side effects included weight gain and feeling the need to move.

Rexulti and other drugs approved to treat schizophrenia include a boxed label warning of the increased risk for death if prescribed for the off-label use to treat behavioral problems in older people with dementia-related psychosis. The boxed warning also expresses caution on the potential for increased suicidal thinking and behavior among children and young adults, a warning common to most antidepressants, the FDA said.

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

Rexulti is produced by Otsuka Pharmaceutical, based in Tokyo.

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