PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--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.”

About schizophrenia

Schizophrenia is a severely debilitating mental illness characterized by delusions, hallucinations, and disordered cognition.^1,2 Based on a systematic review of global data, the prevalence of schizophrenia in 2019 was estimated to be approximately 0.3% and did not vary widely across countries or regions.^3,4 The worldwide lifetime prevalence of the disease has been estimated to be approximately 0.9% across diverse geographic, cultural, and socioeconomic categories. The course of schizophrenia is typically characterized by acute episodes of psychotic behaviors occurring at varying intervals between periods of relative symptomatic stability.¹

About bipolar I disorder

Bipolar I disorder is a recurrent, lifelong mood disorder with a variable course that results in functional and cognitive impairment and a reduction in quality of life that affects 0.6% of the population.^5,6,7 The course of bipolar I disorder is characterized by recurrent manic and depressive episodes that may last weeks or months.⁸ Over 90% of people with bipolar disorder experience recurrences during their lifetimes.⁹

Bipolar I disorder often requires long-term pharmacologic treatment to delay time to recurrence.⁵ Long-acting injectables have the potential to provide continuous delivery of antipsychotic medication and can maintain therapeutic plasma concentrations, which may help address the variable nature of bipolar disorder.¹⁰

About ABILIFY ASIMTUFII (aripiprazole) once-every-two-months, long-acting injectable

ABILIFY ASIMTUFII (aripiprazole), once-every-two-months, long-acting injectable, is provided in a single-chamber, prefilled syringe (PFS) that does not require reconstitution. It is intended for dosing once-every-two-months via intramuscular (IM) injection in the gluteal muscle in the same patient populations as indicated for once-monthly ABILIFY MAINTENA.

Results from the pivotal trial 031-201-00181, that enrolled 266 patients, demonstrated that ABILIFY ASIMTUFII 960 mg met the primary endpoint criteria establishing similarity of aripiprazole plasma concentrations and thus comparable effectiveness to ABILIFY MAINTENA 400 mg over a two-month dosing interval.

Multiple-dose administrations of ABILIFY ASIMTUFII once-every-two-months, LAI 960 mg were generally safe and well tolerated in subjects with schizophrenia or bipolar I disorder and showed comparable safety to aripiprazole once-monthly 400 mg.

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Contacts

Contacts for Media

Otsuka in the U.S.

Robert Murphy
Corporate Communications
Otsuka America Pharmaceutical, Inc.
robert.murphy@otsuka-us.com
+1 609 249 7262

Otsuka outside the U.S.

Jeffrey Gilbert
Leader, Pharmaceutical PR  
Otsuka Pharmaceutical, Co., Ltd.
Gilbert.jeffrey.a@otsuka.co.jp

Lundbeck in the U.S.

Dyana Lescohier
Corporate Communications
Lundbeck US
dyle@lundbeck.com
+1 847 894 3586