US FDA approve Alkermes' injectable Aristada

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).

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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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