A once-monthly intramuscular (IM) depot formulation, the drug has the same efficacy and safety profile as the oral formulation, the manufacturers report.
The FDA approval follows positive results of a phase 3 double-blind, placebo-controlled trial.
First presented at the American Psychiatric Association 2012 Annual Meeting and reported by Medscape Medical News at that time, the study demonstrated that adult outpatients who received the once-monthly IM injections had a significantly greater delay in time to relapse and a significantly lower rate of relapse compared with their counterparts who received placebo.
"Protection from relapse of schizophrenia is important for patients, their families, and the communities in which they live," study investigator John M. Kane, MD, chair of psychiatry at the Zucker Hillside Hospital in Glen Oaks, New York, and from the Hofstra North Shore–Long Island Jewish School of Medicine in Glen Oaks, said in a company release.
"As a strong believer in long-acting therapies for schizophrenia, I think it is important for physicians to have a new and effective once-monthly treatment option that can help reduce the risk of relapse and manage symptoms in patients," he added.
Because of increased morbidity and mortality associated with antipsychotic use in the elderly, the company noted that this drug should not be used in elderly patients with dementia-related psychosis.
The medication is also contraindicated in patients with a known hypersensitivity reaction to aripiprazole.
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Cite this: FDA Approves Once-Monthly Treatment for Schizophrenia - Medscape - Mar 01, 2013.