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治疗精神分裂症的透皮贴剂SECUADO,现已在美国上市

2020-04-14 MedSci原创 MedSci原创

Noven Pharmaceuticals公司宣布SECUADO(阿塞那平)--第一个也是唯一一个获得美国食品和药物管理局(FDA)批准用于治疗精神分裂症的透皮贴剂,现在可以在美国通过处方获得使用。

Noven Pharmaceuticals公司宣布SECUADO(阿塞那平)--第一个也是唯一一个获得美国食品和药物管理局(FDA)批准用于治疗精神分裂症的透皮贴剂,现在可以在美国通过处方获得使用。

SECUADO于2019年10月15日获得FDA批准。该贴剂每24小时施用一次,有3种剂量的阿塞那平可用:3.8毫克/24小时,5.7毫克/24小时和7.6毫克/24小时。每天一次的透皮给药系统可在阿塞那平的佩戴时间(24小时)内维持稳定的浓度。

在双盲、安慰剂的3期对照研究中,SECUADO的两种剂量(3.8 mg/24小时和7.6 mg/24小时)均达到了主要终点和关键次要终点。最常见的不良反应是锥体外系疾病,应用部位反应和体重增加。

精神分裂症是一种严重的慢性精神病,病程和症状特征均不相同。症状通常从16岁到30岁开始,分为三类:正面、负面和认知。正面症状是在健康人中通常不会见到的精神病行为,可能包括幻觉、妄想、思想障碍和运动障碍。负面症状与正常情绪和行为的破坏有关,包括情绪表达减少、日常生活中愉悦感的降低、开始和维持活动的困难以及说话的减少。

原始出处:

https://www.firstwordpharma.com/node/1715200?tsid=4

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    2020-12-27 cenghis
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    2020-04-18 14700f5am15暂无昵称

    这些咨询给人开阔视野

    0

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