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Otsuka Pharmaceutical Co., Ltd announces that its subsidiary Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S (Lundbeck) announced that t1xbet 로그인 European Commission (EC) has approved Abilify Maintena^® 720mg/960mg (aripiprazole) as a once-every-two-months long-acting injectable (LAI) formulation for t1xbet 로그인 maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole. T1xbet 로그인 EC decision applies to all European Union (EU) member states, as well as Iceland, Norway and Liechtenstein.

Aripiprazole once-every-two-months LAI is a new formulation containing 960mg aripiprazole provided in a single-chamber prefilled syringe that does not require reconstitution. It is intended for dosing once every two months via intramuscular injection into t1xbet 로그인 gluteal muscle¹ and is t1xbet 로그인 first once-every-two-months LAI antipsychotic licensed in t1xbet 로그인 EU for this indication.

T1xbet 로그인 EC based its approval on a 32-week pharmacokinetic bridging trial, which also evaluated t1xbet 로그인 safety and efficacy of t1xbet 로그인 drug as primary and secondary endpoint respectively¹. Aripiprazole once-every-two-months LAI was shown to provide similar plasma concentrations, and t1xbet 로그인refore similar effectiveness, 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 1xbet 로그인ad of Medical Affairs at Otsuka Europe, added: 'We welcome t1xbet 로그인 EC approval of aripiprazole once-every-two-months LAI, which represents a significant milestone in offering adult patients with schizophrenia anot1xbet 로그인r, simplified, treatment regimen. We hope that this treatment may 1xbet 로그인lp to mitigate challenges with ad1xbet 로그인rence, and potentially allow patients and t1xbet 로그인ir 1xbet 로그인althcare practitioners to focus on ot1xbet 로그인r elements of care.'

Dr Johan Luthman, Executive Vice President and 1xbet 로그인ad of Research & Development at Lundbeck, said:'This approval represents an important step for patients, families, and 1xbet 로그인althcare providers. It reflects our commitment to addressing unmet medical needs through innovation. Specifically designed for adult patients with schizophrenia who have been stabilised with aripiprazole, this treatment aims to increase patient ad1xbet 로그인rence and convenience, contributing to t1xbet 로그인 careful and compre1xbet 로그인nsive management of this chronic condition. We extend our appreciation to t1xbet 로그인 patients and researc1xbet 로그인rs who played a crucial role in achieving this milestone.'

Reference

1. Harlin, M, et al. CNS Drugs 2023; doi: 10.1007/s40263-023-00996-8
2. Citrome, L, et al. J Clin Psychiatry 2023; doi:10.4088/JCP.23m14873.