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FDA News Release

FDA approves new drug to treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder

For Immediate Release

July 13, 2015



On July 10, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).

Schizophrenia is a chronic, severe, and disabling brain disorder affecting about one percent of Americans. Typically, symptoms are first seen in adults younger than 30 years of age and include hearing voices; believing other people are reading their minds or controlling their thoughts; and being suspicious or withdrawn.

MDD, commonly referred to as depression, is also a severe and disabling brain disorder characterized by mood changes and other symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime, although some may experience a single occurrence. Other signs and symptoms of MDD include loss of interest in usual activities; significant change in weight or appetite; insomnia or excessive sleeping (hypersomnia); restlessness/pacing (psychomotor agitation); increased fatigue; feelings of guilt or worthlessness; slowed thinking or impaired concentration; and suicide attempts or thoughts of suicide. Not all people with MDD experience the same symptoms.

“Schizophrenia and major depressive disorder can be disabling and can greatly disrupt day-to-day activities,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the 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.”

The effectiveness of Rexulti in treating schizophrenia was evaluated 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).

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. 

Rexulti and other drugs used to treat schizophrenia have a Boxed Warning alerting health care professionals about an increased risk of death associated with the off-label use of these drugs 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.

The Boxed Warning also alerts 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. Rexulti must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. 

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.

Rexulti is manufactured by Tokyo-based Otsuka Pharmaceutical Company Ltd.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products


Page Last Updated: 07/14/2015
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