FDA approves once-monthly aripiprazole for schizophrenia

FDA has approved aripiprazole (Abilify Maintena, Otsuka and Lundbeck) for extended-release injectable suspension for the treatment of schizophrenia.

Abilify Maintena is a once-monthly intramuscular (IM) depot formulation that offers the efficacy and safety profile of oral aripiprazole, the first-approved dopamine D₂ partial agonist.

Schizophrenia is a chronic brain disorder characterized by a disruption of thought processes that can cause delusions and hallucinations. The disease affects approximately 2.4 million Americans and 24 million people worldwide, and has serious consequences for patients, their families, and the communities in which they live.

“The development of the new product was prompted by a recognition of the need for additional treatment options in the treatment of schizophrenia,” said John M. Kane, MD, chairman of psychiatry, The Zucker Hillside Hospital, and vice president, Behavioral Health Services, North Shore-LIJ Health System. “The approval is important for managed care and hospital decision-makers because this product is both a once monthly formulation and offers a similar efficacy and safety profile to the oral formulation of aripiprazole, which has been available to treat schizophrenia since 2002.” 

“In my clinical experience, the ability to now have the choice of a familiar medication in an extended-release injection formulation to treat patients with schizophrenia-whose disease causes them to have poor or partial adherence resulting in high rates of relapse and re-hospitalization-is a very important opportunity in terms of serving our patients and possibly reducing costs and improving outcomes,” Dr. Kane said.

Efficacy was demonstrated in a 52-week, placebo-controlled, double-blind, randomized-withdrawal, phase 3 maintenance trial of Abilify Maintena in patients with schizophrenia. The time to relapse was the primary end point. In the trial, Abilify Maintena (n=269 adult patients) significantly delayed time to relapse compared to placebo (n=134 adult patients; hazard ratio=5.03, 95% CI=3.15-8.02, P<.0001).  In a key secondary end point, the percentage of subjects experiencing relapse (ie, meeting clinical trial criteria for exacerbation of psychotic symptoms/relapse) was also significantly lower with Abilify Maintena compared to placebo at the end of the study (10% vs 40%, respectively; P<.0001). Additional support for efficacy was derived from oral aripiprazole trials.

The safety profile of Abilify Maintena is expected to be similar to that of oral aripiprazole. In a randomized phase 3 clinical study, patients who tolerated and responded to oral aripiprazole and single-blind Abilify Maintena who were then randomly assigned to receive Abilify Maintena or placebo injections experienced similar rates of adverse reactions between the two treatment groups. The adverse reaction that was most common (≥ 5% incidence) and occurred at least twice the rate of placebo for oral aripiprazole vs. placebo, respectively, was akathisia (8% vs 4%).

Abilify Maintena is not approved for the treatment of patients with dementia-related psychosis and the medication is contraindicated in patients with a known hypersensitivity reaction to aripiprazole.