Otsuka America Pharmaceutical, Inc. (Otsuka) and Lundbeck announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ABILIFY ASIMTUFII® (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. ABILIFY ASIMTUFII is not approved for the treatment of patients with dementia-related psychosis. ABILIFY ASIMTUFII is contraindicated with a known hypersensitivity reaction to aripiprazole. Please see Important Safety Information below.
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 healthcare 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.
“We are pleased to offer this new treatment option for people living with schizophrenia or bipolar I disorder,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. “This approval underscores Otsuka’s commitment to innovate and continuously evolve to meet the needs of the communities we serve.”
The efficacy of ABILIFY ASIMTUFII is based on the adequate and well-controlled studies of ABILIFY MAINTENA® (aripiprazole) 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.
The once-every-two-months, long-acting injectable formulation in 960 mg and 720 mg prefilled syringes delivers sustained plasma concentrations comparable that demonstrated in studies with ABILIFY MAINTENA, a long-acting injectable, resulting in comparable safety and efficacy.
“This approval is important news for patients, families, and healthcare 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, R&D, Lundbeck. “We are grateful to the patients and researchers who made this major milestone possible.”