FDA has approved aripiprazole (Abilify Maintena, Otsuka and Lundbeck) for extended-release injectable suspension for the treatment of 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,” John M. Kane, MD, chairman of psychiatry, The Zucker Hillside Hospital, and vice president, Behavioral Health Services, North Shore-LIJ Health System, told Formulary. “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 2 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.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More