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The approval of Aristada was based, in part, on the results of a 12-week clinical trial of 623 participants with schizophrenia who were experiencing an acute exacerbation. Participants were randomly assigned to receive a gluteal intramuscular injection of aripiprazole lauroxil (441 mg), aripiprazole lauroxil (882 mg), or matching placebo once monthly for 12 weeks.
Patients in the 441 mg and 882 mg aripiprazole lauroxil groups demonstrated greater improvements in total scores on the Positive and Negative Syndrome Scale and the Clinical Global Impressions-Improvement scale than those treated with placebo. The most common side effects reported by participants receiving the medication were insomnia, headaches, and akathisia.
“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 Center for Drug Evaluation and Research at the FDA. “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.”
Similar to other atypical antipsychotics used to treat schizophrenia, Aristada comes with a Boxed Warning alerting health care professionals about an increased risk of death associated with off-label use of the medication to treat behavioral problems in older adults with dementia-related psychosis. To date, no atypical antipsychotic has been approved to treat dementia-related psychosis.
According to a press release by Alkermes Plc, the manufacturers of Aristada, the newly approved antipsychotic is being prepared to be launched “immediately.”
For related information on aripiprazole, see the Psychiatric News article “FDA To Review Application for Abilify Pill With Ingestible Tracking Device,” featured in most recent issue of PsychoPharm.
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