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.

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