Princeton-based Otsuka America Pharmaceutical Inc., in partnership with Illinois-based Lundbeck, announced the U.S. Food and Drug Administration has approved a new drug application for Abilify Asimtufii, an extended-release injectable aimed to treat schizophrenia and bipolar disorders.
The once-every-two-months injection is geared toward the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. (Abilify Asimtufii is not approved for the treatment of patients with dementia-related psychosis.)
Dr. John Kraus, chief medical officer at Otsuka, was pleased by the approval, which will help the company fulfill its mission.
“This approval underscores Otsuka’s commitment to innovate and continuously evolve to meet the needs of the communities we serve.”
Abilify Asimtufii offers two months of sustained therapeutic concentrations with one dose. Each dose is provided in a single-chamber, prefilled syringe, and is administered by a health care professional to appropriate patients via intramuscular injection in the gluteal muscle. Abilify Asimtufii, a long-acting injectable, provides continuous delivery of medication and can maintain therapeutic plasma concentrations, which may help those living with schizophrenia and bipolar I disorder.
The efficacy of Abilify Asimtufii is based on the adequate and well-controlled studies of Abilify Maintena in the treatment of schizophrenia or maintenance treatment of bipolar I disorder in adults. The aripiprazole concentrations of Abilify Asimtufii were explored in a pharmacokinetic bridging study which was a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study (N=266) in patients living with schizophrenia and bipolar I disorder.
Johan Luthman, executive vice president, research & development, at Lundbeck, said the treatment may have great impact.
“This approval is important news for patients, families and health care providers,” he said. “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.”