![]() 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 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. “This approval underscores Otsuka’s commitment to innovate and continuously evolve to meet the needs of the communities we serve.” “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. 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. ![]() 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. Please see Important Safety Information below.ĪBILIFY ASIMTUFII offers two months of sustained therapeutic concentrations with one dose. ABILIFY ASIMTUFII is contraindicated with a known hypersensitivity reaction to aripiprazole. ABILIFY ASIMTUFII is not approved for the treatment of patients with dementia-related psychosis. 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.Įlderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. & DEERFIELD, Ill.-( BUSINESS WIRE)-Otsuka America Pharmaceutical, Inc.
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