Abilify Asimtufii is a long-acting, extended-release injectable suspension given via injection in the gluteal muscle. Credit: Diana Polekhina on Unsplash.

Otsuka America Pharmaceutical and Lundbeck have received approval from the US Food and Drug Administration (FDA) for a new drug application for Abilify Asimtufii (aripiprazole) to treat schizophrenia or for maintenance monotherapy treatment of bipolar I disorder in adult patients.

Abilify Asimtufii is a long-acting, extended-release injectable suspension offering sustained therapeutic concentrations via one dose every two months through intramuscular injection in the gluteal muscle.

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It offers continuous delivery of medication and maintains therapeutic plasma concentrations.

Otsuka stated that the therapy is contraindicated in patients with a known hypersensitivity reaction to aripiprazole and is not approved to treat dementia-related psychosis in patients.

Otsuka executive vice-president and chief medical officer John Kraus stated: “We are pleased to offer this new treatment option for people living with schizophrenia or bipolar I disorder.

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“This approval underscores Otsuka’s commitment to innovate and continuously evolve to meet the needs of the communities we serve.”

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Abilify Asimtufii’s efficacy is based on the well-controlled trial of Abilify Maintena (aripiprazole) to treat schizophrenia or for maintenance treatment of bipolar I disorder in adult patients.

Its aripiprazole concentrations were explored in a multiple-dose, 32-week, parallel-arm, multicentre, open-label, randomised, pharmacokinetic bridging trial, which was conducted in 266 schizophrenia and bipolar I disorder patients.

Lundbeck research and development executive vice-president Johan Luthman stated: “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.”

Lundbeck and Otsuka also signed an agreement for the development and commercialisation of five products related to psychiatry, including aripiprazole depot formulation and OPC-34712 from Otsuka.