HealthDay News — Aristada (aripiprazole lauroxil) extended-release injection has been approved by the U.S. Food and Drug Administration to treat schizophrenia, the agency said in a news release.

Aristada’s effectiveness was demonstrated in a 12-week clinical study involving 622 patients. 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 was akathisia.

As with other atypical antipsychotics, Aristada includes a boxed warning against off-label use that may increase the risk of death among older people with dementia-related psychosis.

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“Long-acting medications to treat schizophrenia can improve the lives of patients,” Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

Aristada is manufactured by Alkermes, Inc., based in Waltham, Mass.


FDA. FDA News Release. FDA approves new injectable drug to treat schizophrenia. October 6, 2015.