FDA Approves Aripiprazole as Once-Every-2-Months Long-Acting Injectable for Schizophrenia, Bipolar I Disorder

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The FDA has approved ABILIFY ASIMTUFII®, a long-acting injectable medication, for treating schizophrenia and bipolar I disorder. It is administered once every two months by a healthcare professional.
ABILIFY ASIMTUFII® is a single-chamber, prefilled syringe that does not require reconstitution. It is available in 960 mg and 720 mg doses. The formulation delivers sustained plasma concentrations comparable to those demonstrated in studies with Abilify Maintena, a long-acting injectable.

The efficacy of Abilify Asimtufii is based on the adequate and well-controlled studies of Abilify Maintena for schizophrenia and bipolar I disorder. The concentrations of Abilify Asimtufii were explored in a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter, pharmacokinetic bridging study. The study included 266 patients.
The results demonstrated that Abilify Asimtufii 960 mg met the primary endpoint criteria establishing the similarity of aripiprazole plasma concentrations and, therefore, comparable efficacy to Abilify Maintena 400 mg over a 2-month dosing interval.
Multiple-dose administrations of Abilify Asimtufii once every two months were generally safe and well tolerated in subjects with schizophrenia or bipolar I disorder. They showed comparable safety to aripiprazole once-monthly 400 mg.

Schizophrenia and bipolar I disorder are serious mental illnesses that can significantly impact a person’s life. Delusions, hallucinations, and disordered thinking characterize schizophrenia. In contrast, bipolar I disorder is characterized by extreme mood swings, including mania and depression.
There is no cure for either schizophrenia or bipolar I disorder, but effective treatments are available. Abilify Asimtufii is a new option for long-term treatment that may help improve outcomes and reduce the burden of these illnesses.


FDA Approves Otsuka and Lundbeck’s Abilify Asimtufii (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults. News release. Otsuka. April 27, 2023. Accessed April 28, 2023.


PRINCETON, NJ and DEERFIELD, IL – (April 27, 2023) – Otsuka America Pharmaceutical, Inc. (Otsuka) and Lundbeck announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ABILIFY ASIMTUFII® (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults.


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