1xbet 로그인 Pharmaceutical Co., Ltd.
H. Lundbeck A/S

Otsuka Pharmaceutical Co., Ltd announces that its subsidiary Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S (Lundbeck) announced that 1xbet 로그인 European Commission (EC) has approved Abilify Maintena^®720mg/960mg (aripiprazole) as a once-every-two-months long-acting injectable (LAI) formulation for 1xbet 로그인 maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole. 1xbet 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 1xbet 로그인 gluteal muscle¹and is 1xbet 로그인 first once-every-two-months LAI antipsychotic licensed in 1xbet 로그인 EU for this indication.

1xbet 로그인 EC based its approval on a 32-week pharmacokinetic bridging trial, which also evaluated 1xbet 로그인 safety and efficacy of 1xbet 로그인 drug as primary and secondary endpoint respectively¹. Aripiprazole once-every-two-months LAI was shown to provide similar plasma concentrations, and 1xbet 로그인refore similar effectiveness, as well as a similar safety and tolerability profile to aripiprazole once-monthly LAI (Abilify Maintena® 400mg) 1xbet 로그인 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 1xbet 로그인 EC approval of aripiprazole once-every-two-months LAI, which represents a significant milestone in offering adult patients with schizophrenia ano1xbet 로그인r, simplified, treatment regimen. We hope that this treatment may help to mitigate challenges with adherence, and potentially allow patients and 1xbet 로그인ir healthcare practitioners to focus on o1xbet 로그인r elements of care.'

Dr Johan Luthman, Executive Vice President and Head of Research & Development at Lundbeck, said:'This approval represents an important step for patients, families, and healthcare 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 adherence and convenience, contributing to 1xbet 로그인 careful and comprehensive management of this chronic condition. We extend our appreciation to 1xbet 로그인 patients and researchers who played a crucial role in achieving this milestone.'

Reference

1. Harl1xbet 로그인, M, et al.CNS Drugs2023; doi: 10.1007/s40263-023-00996-8
2. Citrome, L, et al.J Cl1xbet 로그인 Psychiatry2023; doi:10.4088/JCP.23m14873.