大冢（Otsuka）和灵北（Lundbeck）2月14日宣布，长效版抗精神病药物Abilify Maintena（aripiprazole，阿立哌唑）获加拿大卫生部批准，作为每月一次的肌内注射（IM）剂型药物，用于口服阿立哌唑稳定病情的精神分裂症（schizophrenia）成人患者的维持治疗，该药是唯一获批的每月一次的注射剂型多巴胺D2部分激动剂。此前，Abilify Maintena于2013年11月获欧盟批准。

Abilify Maintena将成为大冢-灵北全球联盟在加拿大推出的首个商业化产品，该药预计将于2014年4月在加拿大上市。

防止复发是治疗精神分裂症的关键。支持Abilify Maintena监管文件的关键性研究证明，在精神分裂症的长期治疗中，与安慰剂相比，Abilify Maintena能够降低复发的风险，同时疗效不逊色于口服阿立哌唑。

Abilify Maintena具有与口服阿立哌唑类似的耐受性，与安慰剂相比，Abilify Maintena在患者个人和社会功能上表现出统计学意义的显著改善，在双盲治疗阶段结束时，高达93%的患者对Abilify Maintena治疗表现出及其满意、非常满意或有点满意。

英文原文：

Published 14 February 2014

Otsuka and Lundbeck has received approval from Health Canada to use its intramuscular (IM) once-monthly injectable formulation 'Abilify Maintena' for the maintenance treatment of schizophrenia in stabilized adult patients.

Abilify Maintena will be the first commercialized product in Canada from the global Otsuka- Lundbeck alliance, which is focused on developing Central Nervous System (CNS) therapies worldwide.

The two firms expect that the once-monthly injectable formulation will be available in Canada in April 2014.

The drug is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maintenance treatment in schizophrenia.

It helps in reducing the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia.

The controlled clinical trials show that the drug is significantly superior compared to non-active treatments (placebo or pseudo-placebo) in the prevention of psychotic symptoms/impending relapse for up to 38 weeks after stabilization with oral aripiprazole.

Additionally, efficacy of the drug was calculated in two pivotal trials and is found to be comparable to that of oral aripiprazole with a similar tolerability profile.

关键词： 大冢 灵北 精神分裂症 Abilify Maintena 阿立哌唑 长效版抗精神病药物

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