FDA Approves ABILIFY ASIMTUFII for Schizophrenia and Bipolar Disorder Treatment

Otsuka America Pharmaceutical and Lundbeck announced Thursday that the US Food and Drug Administration (FDA) approved ABILIFY ASIMTUFII (aripiprazole), a long-acting injectable (LAI) medication for the treatment of schizophrenia and bipolar I disorder. 

“This approval is important news for patients, families, and healthcare providers,” Johan Luthman, executive vice president, R&D, Lundbeck, said in a press release. “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. We are grateful to the patients and researchers who made this major milestone possible.”

Related: FDA Approves Bi-Weekly Extended-Release Risperidone for Schizophrenia and Bipolar I

ABILIFY ASIMTUFII offers 2 months of sustained therapeutic concentrations with a single dose, administered via intramuscular injection. The LAI provides continuous delivery of medication, which can help patients with schizophrenia and bipolar disorder continue treatment progress.

Approval was based on the results of a 32-week, open-label, randomized pharmacokinetic bridging study on 266 patients with schizophrenia and bipolar I disorder. 

The medication is not approved for treating dementia-related psychosis in elderly patients. The approval was based on studies on ABILIFY MAINTENA (aripiprazole) in the treatment of schizophrenia or maintenance treatment of bipolar I disorder in adults. 

Reference
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. Otsuk