Posted from: Monday, October 31, 2016 - 03:17 PM - Present

Labeling Update for Rexulti

September 23, 2016 - The U.S. FDA approved Rexulti® (brexpiprazole) to include the results from a clinical trial in its prescribing information and labeling can now include information about its use as schizophrenia maintenance therapy. The FDA approved Rexulti in July 2015 as a single therapy to treat schizophrenia and as add-on treatment for major depression. The continuation of a previous trial found that patients with schizophrenia who were stabilized on Rexulti and kept taking it had longer times to relapse than study patients who were switched to an inactive placebo. Rexulti is an atypical antipsychotic that is believed to work by partially activating both dopamine and serotonin receptors to help regulate neurotransmitter levels. A boxed warning cautions that Rexulti should not be used by elderly patients with psychosis due to dementia and that patients younger than 24 years of age should be watched for behavioral changes while they take it. Rexulti was developed jointly by H. Lundbeck A/S and Otsuka Pharmaceutical Company.


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Last Updated Tuesday, October 22, 2019 - 03:59 PM.