An overview of the efficacy and safety of brexpiprazole for the treatment of schizophrenia in adolescents.

IF 3.4 2区 医学 Q2 CLINICAL NEUROLOGY Expert Review of Neurotherapeutics Pub Date : 2024-08-01 Epub Date: 2024-07-05 DOI:10.1080/14737175.2024.2367695
Chesika J Crump, Hagar Abuelazm, Kirolos Ibrahim, Shaishav Shah, Rif S El-Mallakh
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Abstract

Introduction: The onset of psychotic symptoms occurs prior to age 19 in 39% of the patients with schizophrenia. There are limited approved treatment options for adolescents with schizophrenia. Brexpiprazole was approved by the United States Food and Drug Administration (FDA) for treatment of schizophrenia in adolescents in 2022.

Areas covered: Extrapolation of adult data to youth and use of pharmacologic modeling coupled with open long-term safety data were used by the FDA to approve brexpiprazole for adolescent schizophrenia. They were all reviewed herein.

Expert opinion: D2 receptor partial agonist antipsychotic agents are preferred in the early phase of treatment of psychotic disorders. Approval of brexpiprazole in adolescent schizophrenia provides an additional option. Brexpiprazole was approved by the FDA on the basis of extrapolation of adult data without controlled trials in adolescents. This reduces placebo exposure in young people. Two previous agents (asenapine and ziprasidone) approved for adult schizophrenia failed to separate from placebo in adolescent schizophrenia studies; this partially undermines the process of extrapolation. For brexpiprazole, the paucity of data in adolescents relegates it to a second-line agent. More research on brexpiprazole is needed to delineate its relative role in the management of adolescent schizophrenia.

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概述布来匹唑治疗青少年精神分裂症的疗效和安全性。
导言:39%的精神分裂症患者在 19 岁之前就会出现精神症状。目前,针对青少年精神分裂症患者的获批治疗方案十分有限。美国食品和药物管理局(FDA)于2022年批准布雷哌唑用于治疗青少年精神分裂症:美国食品和药物管理局通过将成人数据外推至青少年、使用药理学模型以及公开的长期安全性数据,批准布雷克哌唑用于治疗青少年精神分裂症。本文对这些内容进行了综述:专家意见:D2受体部分激动剂类抗精神病药物是治疗精神障碍早期阶段的首选药物。在青少年精神分裂症的治疗中,布雷克吡唑的获批提供了另一种选择。美国食品和药物管理局批准布雷克哌唑的依据是对成人数据的推断,而没有在青少年中进行对照试验。这减少了青少年接触安慰剂的机会。之前批准用于成人精神分裂症的两种药物(阿塞那平和齐拉西酮)在青少年精神分裂症研究中未能与安慰剂区分开来;这在一定程度上破坏了外推过程。对于布来哌唑来说,青少年研究数据的匮乏使其只能作为二线药物使用。需要对布来哌唑进行更多的研究,以确定其在治疗青少年精神分裂症中的相对作用。
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来源期刊
Expert Review of Neurotherapeutics
Expert Review of Neurotherapeutics Medicine-Neurology (clinical)
CiteScore
7.00
自引率
2.30%
发文量
61
审稿时长
4-8 weeks
期刊介绍: Expert Review of Neurotherapeutics (ISSN 1473-7175) provides expert reviews on the use of drugs and medicines in clinical neurology and neuropsychiatry. Coverage includes disease management, new medicines and drugs in neurology, therapeutic indications, diagnostics, medical treatment guidelines and neurological diseases such as stroke, epilepsy, Alzheimer''s and Parkinson''s. Comprehensive coverage in each review is complemented by the unique Expert Review format and includes the following sections: Expert Opinion - a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results Article Highlights – an executive summary of the author’s most critical points
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