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.Ībilify Asimtufii (aripiprazole), once-every-two-months, long-acting injectable, is provided in a single-chamber, prefilled syringe (PFS) that does not require reconstitution. Over 90% of people with bipolar disorder experience recurrences during their lifetimes.īipolar I disorder often requires long-term pharmacologic treatment to delay time to recurrence. The course of bipolar I disorder is characterized by recurrent manic and depressive episodes that may last weeks or months. The course of schizophrenia is typically characterized by acute episodes of psychotic behaviors occurring at varying intervals between periods of relative symptomatic stability.īipolar 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. The worldwide lifetime prevalence of the disease has been estimated to be approximately 0.9% across diverse geographic, cultural, and socioeconomic categories. 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.
Schizophrenia is a severely debilitating mental illness characterized by delusions, hallucinations, and disordered cognition. "We are grateful to the patients and researchers who made this major milestone possible." 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. "This approval is important news for patients, families, and healthcare providers. The once-every-two-months, long-acting injectable formulation in 960 mg and 720 mg prefilled syringes delivers sustained plasma concentrations similar to that demonstrated in studies with aripiprazole monohydrate once-monthly, long-acting injectable, resulting in similar sustained efficacy. 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 that may delay the time to relapse," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka Pharmaceutical Development & Commercialization, Inc. Long-acting injectables provide continuous delivery of antipsychotic medication and can maintain therapeutic plasma concentrations, which may help to maintain symptom control of schizophrenia and bipolar I disorder.
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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.
(Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the US 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.Ībilify Asimtufii offers two months of sustained therapeutic concentrations with one dose. US FDA approves Otsuka & Lundbeck's Abilify Asimtufii, the first, two-month, LAI to treat schizophrenia or maintenance monotherapy treatment of bipolar I disorder in adults You can get e-magazine links on WhatsApp.
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