The U.S. Food and Drug Administration (FDA) has approved a new drug application for the once-every-two-months long-acting injectable version of aripiprazole (ABILIFY ASIMTUFII, Otsuka and Lundbeck) for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. The approval is supported by clinical data demonstrating efficacy and well-established tolerability.
The aripiprazole long-acting injectable offers two months of sustained therapeutic concentrations with one dose. Each dose is provided in a single-chamber, prefilled syringe, and is administered by a healthcare professional via intramuscular injection in the gluteal muscle. The once-every-two-months, long-acting injectable formulation in 960 mg and 720 mg prefilled syringes delivers sustained plasma concentrations comparable that demonstrated in studies with ABILIFY MAINTENA, a long-acting injectable, resulting in comparable safety and efficacy. Multiple-dose administrations of aripiprazole long-acting injectable once-every-two-months, 960 mg were generally safe and well tolerated in subjects with schizophrenia or bipolar I disorder and showed comparable safety to aripiprazole once-monthly 400 mg.
>> Otsuka America Pharmaceutical, Inc. and Lundbeck Press Release
For more information:
NEI Podcast Episode 135 - (CME) The Art of Switching Antipsychotics to Better Treat Patients with Schizophrenia CME/CE credits: 1.00 | Expires: January 26, 2025
Encore Presentation Early Use of LAI Antipsychotics for Patient Adherence, Relapse Prevention, and Brain Preservation CME/CE credits: 0.75 | Expires: November 6, 2025
Encore Presentation Jeopardy! Long-Acting Injectables CME/CE credits: 0.50 | Expires: April 24, 2025
Encore Presentation Pragmatic Precision Psychiatry: Utilizing Pharmacokinetics and Pharmacodynamics to Optimize Antipsychotic Treatment CME/CE credits: 0.75 | Expires: November 3, 2025
CME/CE Article Practical Guide for Converting to a Long-Acting Injectable Antipsychotic CME/CE credits: 0.50 | Expires: April 26, 2025
Encore Presentation Tipping the Scales: Overcoming Antipsychotic Side Effects to Improve Treatment Adherence CME/CE credits: 1.00 | Expires: November 6, 2025
NEI Membership Learn about NEI Membership benefits