The US Food and Drug Administration approved Alkermes Inc's Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia. 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. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.
The efficacy of Aristada was demonstrated in part by a 12-week clinical trial in 622 participants. In participants with acute schizophrenia who had been stabilized with oral aripiprazole, Aristada was found to maintain the treatment effect compared to a placebo. The most common side effect reported by participants receiving Aristada in clinical trials was feeling the urge to move constantly (akathisia).
Aristada and other atypical antipsychotic 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. Aristada must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks.
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