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FDA接受Alkermes重新提交ALKS 3831治疗精神分裂症的新药申请

2020-12-30 Allan MedSci原创

精神分裂症是一种精神病,一种以思维、观点、情绪、语言、自我意识和行为出现扭曲为特征的精神疾患。

精神分裂症是一种精神病,一种以思维、观点、情绪、语言、自我意识和行为出现扭曲为特征的精神疾患。双相障碍的命名源于该心境障碍兼有两种情感的极端状态或者是两极——抑郁状态和躁狂状态。约有 4% 的美国人存在不同程度的双相障碍。男女患病率相同。发病时间通常在十几岁、20 几岁或 30 几岁时。

制药公司Alkermes今天宣布,美国食品药品监督管理局(FDA)已确认已收到该公司针对ALKS 3831(olanzapine / samidorphan)新药申请(NDA)的重新提交,旨在用于治疗精神分裂症成人和患有精神分裂症的成人I型双相情感障碍。

在完成对ALKS 3831 NDA的审查后,Alkermes将继续与FDA紧密合作,并致力于将ALKS 3831尽快提供给患者。

ALKS 3831是一种研究性、新颖的、每日一次的口服非典型抗精神病候选药物,用于治疗精神分裂症和双相I型障碍患者。ALKS 3831由samidorphan(一种新型的新分子实体)组成,与一种既有的抗精神病药olanzapine共同配制在一个双层片剂中。

 

原始出处:

https://www.firstwordpharma.com/node/1787063?tsid=4

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    2021-01-01 仁心济世

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