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FDA approves Aristada for schizophrenia
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The FDA recently approved Aristada, an extended-release injection drug, to treat schizophrenia in adults, according to a press release.
Aristada (aripiprazole lauroxil, Alkermes) is administered every 4 to 6 weeks via an injection in the arm or buttocks.
Safety and efficacy of the newly approved drug was demonstrated in a 12-week clinical trial that included 622 study participants.
Researchers found aripiprazole lauroxil maintained treatment effect among participants with acute schizophrenia who had been stabilized with oral aripiprazole.
Akathisia was the most common reported side effect of aripiprazole lauroxil.
As with all other atypical antipsychotic drugs used to treat schizophrenia, aripiprazole lauroxil has a Boxed Warning regarding an increased risk for death associated with off-label use to treat behavioral problems among older adults with dementia-related psychosis. No drug in this class is approved to treat dementia-related psychosis.
“Long-acting medications to treat schizophrenia can improve the lives of patients,” Mitchell Mathis, MD, director of the division of psychiatry products at the FDA’s Center for Drug Evaluation and Research, said in the release. “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.”