FDA Approves Bi-Monthly Aripiprazole Injection for Schizophrenia, Bipolar Disorder

The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for aripiprazole extended-release injectable suspension (ABILIFY ASIMTUFII) as a bi-monthly injection treatment for adults with schizophrenia or bipolar I disorder (BPD).

The approval granted to Otsuka American Pharmaceutical and Lundbeck offers diverse utility of the intramuscular long-acting injectable (LAI) as administered once every 2 months through a prefilled syringe—either as a general treatment for schizophrenia or a maintenance monotherapy for BPD.

Aripiprazole’s approval was supported by findings from a 32-week, open-label, multiple-dose, randomized, parallel-arm pharmacokinetic bridging analysis involving 266 patients with schizophrenia and BPD across multiple care centers. Investigators assessed 960 mg and 720 mg doses across trial participants; both doses met the primary endpoint criteria indicating a similarity of aripiprazole plasma concentrations and therefore comparable efficacy to the previously approved once-monthly 400 mg treatment dose.

Investigators additionally observed generally safe and tolerable outcomes with the 960 mg dose of aripiprazole in patients with schizophrenia or BPD, as well as a comparable safety profile to once-monthly 400 mg doses.

ABILIFY ASIMTUFII is contraindicated with a known hypersensitivity reaction to aripiprazole; the new indication includes safety information regarding increased risk of death in elderly people with dementia-related psychosis, as well as severe adverse events including stroke risk, neuroleptic malignant syndrome, or tardive dyskinesia.

In a statement accompanying the announced approval, Lundbeck executive vice president of R&D Johan Luthman stressed the importance of the new dosage indications for patients, families and health care providers impacted by schizophrenia and/or BPD.

“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,” Luthman said. “We are grateful to the patients and researchers who made this major milestone possible.”

References

1. ^{Otsuka. Press release. 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. Published April 28, 2023. https://otsuka-us.com/news/fda-approves-otsuka-and-lundbecks-abilify-asimtufiir-aripiprazole-first-once-every-two-months}