FDA Approves Aristada
FDA Approves Aristada (aripiprazole lauroxil) for Schizophrenia
October 6, 2015 -- On October 5, the U.S. Food and Drug Administration approved Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.
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hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.
“Long-acting medications to treat schizophrenia can improve the lives of patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Having a variety of treatment options and dosage forms available for patients with mental illness is important so that a treatment plan can be tailored to meet the patient’s needs.”
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.
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.
The most common side effect reported by participants receiving Aristada in clinical trials was feeling the urge to move constantly (akathisia).
Aristada is manufactured by Alkermes, Inc. of Waltham, Massachusetts.
Posted: October 2015
- FDA Approves Aristada Initio (aripiprazole lauroxil) for the Initiation of Aristada for Schizophrenia - July 2, 2018
- FDA Approves Two-Month Aristada for Treatment of Schizophrenia - June 6, 2017
- Alkermes Provides Update on FDA Review of Aristada for the Treatment of Schizophrenia - August 21, 2015
- Aripiprazole Lauroxil Phase 3 Schizophrenia Study Results Published in Journal of Clinical Psychiatry - June 9, 2015
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