FDA Approves Longer-Acting Aripiprazole for Schizophrenia

Alicia Ault

June 06, 2017

The US Food and Drug Administration (FDA) has approved a 2-month dose of aripiprazole lauroxil (Aristada, Alkermes) extended-release injectable suspension for the treatment of schizophrenia.

The long-acting injectable was first approved by the FDA in October 2015. With the latest approval, Alkermes' aripiprazole will be available in four doses with three options for dosing duration (441 mg, 662 mg, or 882 mg once monthly; 882 mg once every 6 weeks; and 1064 mg once every 2 months). Aripiprazole can be initiated at any dose or interval.

The new 2-month dose is expected to be available in mid-June, according to Alkermes, which is based in Dublin, Ireland.

"The availability of an antipsychotic that can be initiated prior to hospital discharge and provide therapeutic levels of medication for 2 months will be a welcome new treatment option for healthcare providers, caregivers, and patients," said Joseph McEvoy, MD, I. Clark Case Distinguished Chair in Psychotic Disorders at Augusta University and professor emeritus of psychiatry and behavioral health at Duke University Medical Center, Durham, North Carolina, in a statement issued by Alkermes.

Aripiprazole lauroxil and other atypical antipsychotics carry a boxed warning alerting healthcare professionals about an increased risk for death associated with the off-label use of these drugs to treat behavioral problems in older patients with dementia-related psychosis.

In May 2016, the FDA warned that the atypicals, including aripiprazole lauroxil, have been found to be associated with impulse control problems, including compulsive gambling, eating, shopping, and sexual activity.


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