FDA Clears Long-Acting Aripiprazole for Schizophrenia

Megan Brooks

October 06, 2015

The US Food and Drug Administration (FDA) has approved an injectable, long-acting version of Alkermes Inc's atypical antipsychotic aripiprazole to treat adults with schizophrenia.

Aripiprazole lauroxil (Aristada) is administered every 4 to 6 weeks as an injection in the arm or buttocks. The company said it expects to launch the drug in the "immediately."

"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 an FDA news release announcing the approval. "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," he said.

The approval of aripiprazole lauroxil was based on data from a randomized, double-blind, placebo-controlled, phase 3 study in more than 600 patients with schizophrenia.

Data from that trial showed that multiple dose strengths of aripiprazole lauroxil met the primary end point with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale total scores at week 12.

The study also met the prespecified secondary end point of improvement in the Clinical Global Impression–Improvement scale score at week 12 and demonstrated significant improvements in schizophrenia symptoms vs placebo.

Aripiprazole lauroxil was generally well tolerated, and its safety profile was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia, and headache.

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. "No drug in this class is approved to treat patients with dementia-related psychosis," the FDA notes.

"Schizophrenia is a serious and debilitating disease where, despite the existence of many medicines, there remains significant unmet medical need and suffering. New treatment options are needed to help patients and their families better manage this illness," David Henderson, MD, associate professor of psychiatry at Massachusetts General Hospital, in Boston, said in a company news release.

"Long-acting therapies are rapidly evolving to the forefront of the treatment of schizophrenia as clinicians increasingly recognize the potential benefits of less frequent dosing and consider their use earlier in disease progression," he added.

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