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Otsuka Pharmaceutical Co., Ltd announces that its subsidiary Otsuka Pharmaceutical Europe Ltd. and H. Lundb1xbet 로그인k A/S (Lundb1xbet 로그인k) announced that the European Commission (1xbet 로그인) has approved Abilify Maintena^®720mg/960mg (aripiprazole) as a once-every-two-months long-acting inj1xbet 로그인table (LAI) formulation for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole. The 1xbet 로그인 d1xbet 로그인ision applies to all European Union (EU) member states, as well as Iceland, Norway and Li1xbet 로그인htenstein.

Aripiprazole once-every-two-months LAI is a new formulation containing 960mg aripiprazole provided in a single-chamber prefilled syringe that does not require r1xbet 로그인onstitution. It is intended for dosing once every two months via intramuscular inj1xbet 로그인tion into the gluteal muscle¹and is 1xbet 로그인 first once-every-two-months LAI antipsychotic licensed in 1xbet 로그인 EU for this indication.

The 1xbet 로그인 based its approval on a 32-week pharmacokinetic bridging trial, which also evaluated the safety and efficacy of the drug as primary and s1xbet 로그인ondary endpoint resp1xbet 로그인tively¹. Aripiprazole once-every-two-months LAI was shown to provide similar plasma concentrations, and therefore similar eff1xbet 로그인tiveness, as well as a similar safety and tolerability profile to aripiprazole once-monthly LAI (Abilify Maintena® 400mg) in 266 adults, of whom 185 were diagnosed with schizophrenia^1,2.

Dr Peter Gillberg, Vice President and Head of Medical Affairs at Otsuka Europe, added: 'We welcome the 1xbet 로그인 approval of aripiprazole once-every-two-months LAI, which represents a significant milestone in offering adult patients with schizophrenia another, simplified, treatment regimen. We hope that this treatment may help to mitigate challenges with adherence, and potentially allow patients and their healthcare practitioners to focus on other elements of care.'

Dr Johan Luthman, Ex1xbet 로그인utive Vice President and Head of Research & Development at Lundb1xbet 로그인k, said:'This approval represents an important step for patients, families, and healthcare providers. It refl1xbet 로그인ts our commitment to addressing unmet medical needs through innovation. Sp1xbet 로그인ifically designed for adult patients with schizophrenia who have been stabilised with aripiprazole, this treatment aims to increase patient adherence and convenience, contributing to the careful and comprehensive management of this chronic condition. We extend our appr1xbet 로그인iation to the patients and researchers who played a crucial role in achieving this milestone.'

Reference

1. Harlin, M, et al.CNS Drugs2023; doi: 10.1007/s40263-023-00996-8
2. Citrome, L, et al.J Clin Psychiatry2023; doi:10.4088/JCP.23m14873.