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.
Schizophrenia is a chronic, disabling brain disorder that primary affects people aged 30 and younger. Affecting about 1 percent of Americans, the disorder is characterized by hearing voices, believing other people are reading your mind, withdrawal and suspicion.
MDD, commonly called depression, is characterized by unhappy mood that interferes with a person's ability to carry on life's daily activities. Other symptoms may include loss of interest in daily life, weight change, insomnia, restlessness, fatigue, feeling guilty or worthless, and inability to concentrate.
Clinical studies evaluating the drug for both disorders 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.
Rexulti is produced by Otsuka Pharmaceutical Co., based in Tokyo.
The FDA has more about this approval.