Aripiprazole will be the first 2-month LAI antipsychotic indicated for both the treatment of schizophrenia and the maintenance treatment of bipolar I disorder in the United States.
The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for aripiprazole (Abilify Asimtufii) 2-month, ready-to-use, extended-release injectable for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. This is the first 2-month LAI antipsychotic indicated for both the treatment of schizophrenia and the maintenance treatment of bipolar I disorder in the United States.1,2
“We are pleased to offer this new treatment option for people living with schizophrenia or bipolar I disorder,” said John Kraus, MD, PhD, chief medical officer and executive vice president at Otsuka.
One dose of this long-acting injectable provides 2 months of sustained therapeutic concentrations. Doses are provided in a single-chamber, prefilled syringe of either 960 mg or 720 mg, and are administered by a health care professional via gluteal muscle intramuscular injection. Concentrations of aripiprazole were investigated in a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study (N=266) in patients with schizophrenia and bipolar I disorder.
“This approval is important news for patients, families, and health care providers. 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 at Lundbeck. “We are grateful to the patients and researchers who made this major milestone possible.”
1. 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. Otsuka. News release. 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
2. Kuntz L. NDA for long-acting injectable for schizophrenia and bipolar I accepted. Psychiatric Times. September 13, 2022. https://www.psychiatrictimes.com/view/nda-for-long-acting-injectable-for-schizophrenia-and-bipolar-i-accepted