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


The formulation in 960 mg and 720 mg prefilled syringes delivers sustained plasma concentrations comparable to those demonstrated in studies with Abilify Maintena.

Officials with the FDA have approved aripirazole (Abilify Asimtufii, Otsuka and Lundbeck) as the first extended-release injectable suspension for intramuscular use, administered once every 2 months for the treatment of schizophrenia or for maintenance monotherapy treatment of bipolar I disorder in adults.

Credit: Olivier Le Moal - stock.adobe.com

Credit: Olivier Le Moal - stock.adobe.com

The treatment is provided in a single-chamber, prefilled syringe that does not require reconstitution. The formulation in 960 mg and 720 mg prefilled syringes delivers sustained plasma concentrations comparable to those demonstrated in studies with Abilify Maintena, a long-acting injectable, resulting in comparable safety and efficacy.

The newly approved formulation offers 2 months of sustained therapeutic concentration with a single dose administered by a health care professional via intramuscular injection in the gluteal muscle. It provides continuous delivery of medication and can maintain therapeutic plasma concentrations, which may help individuals living with schizophrenia and bipolar I disorder.

The efficacy of the treatment is based on the adequate and well-controlled studies of Abilify Maintena for schizophrenia or maintenance treatment of bipolar I disorder in adults. 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 aripirazole 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 2 months were generally safe and well tolerated in subjects with schizophrenia or bipolar I disorder and showed comparable safety to aripirazole once-monthly 400 mg.

“This approval is important news for patients, families, and health care workers. We hope that the use of Abilify Asimtufii in treatment plans will have a positive impact on those living with schizophrenia or bipolar I disorder,” said Johan Luthman, executive vice president of research and development at Lundbeck, in a press release. “We are grateful to the patients and researchers who made this major milestone possible.”

Schizophrenia and bipolar I disorder are both complex and challenging illnesses. Schizophrenia is characterized by delusions, hallucinations, and disordered cognition, and is estimated to affect approximately 0.3% of the global population. The course of schizophrenia is typically characterized by acute episodes of psychotic behaviors occurring at varying intervals between periods of relative symptomatic stability.

Bipolar I disorder is a recurrent, lifelong mood disorder with a variable course that causes functional and cognitive impairment and a reduction in quality of life. It impacts approximately 0.6% of the global population and is characterized by recurrent manic and depressive episodes that may last weeks or months. More than 90% of individuals with bipolar disorder experience recurrences during their lifetimes.

Bipolar I disorder often requires long-term pharmacologic treatment to delay time to recurrence. Long acting injectables could potentially provide continuous delivery of antipsychotic medication and can maintain therapeutic plasma concentrations, which may help address the variable nature of the disorder.


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. https://www.otsuka-us.com/news/fda-approves-otsuka-and-lundbecks-abilify-asimtufiir-aripiprazole-first-once-every-two-months

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