FDA批准美金刚胺/多奈哌齐(Namzaric)组合药剂用于治疗阿尔茨海默氏症

2015-01-04 MedSci MedSci原创

美国食品药品监督管理局(FDA)批准固定剂量复方制剂的盐酸美金刚延长释放制剂(XR)和盐酸多奈哌齐(Namzaric,阿特维斯制药 /Adamas Pharm)治疗中度到重度老年痴呆症，患者接受稳定的两种药物剂量。美金刚XR(Namenda XR, 阿特维斯制药)是一个由N-甲基-D-天门冬氨酸抑制剂，和多奈哌齐(安理申,辉瑞)一种乙酰胆碱酯酶抑制剂(AChEI)。“在一个胶囊里Namzari

美国食品药品监督管理局(FDA)批准固定剂量复方制剂的盐酸美金刚延长释放制剂(XR)和盐酸多奈哌齐(Namzaric,阿特维斯制药 /Adamas Pharm)治疗中度到重度老年痴呆症，患者接受稳定的两种药物剂量。

美金刚XR(Namenda XR, 阿特维斯制药)是一个由N-甲基-D-天门冬氨酸抑制剂，和多奈哌齐(安理申,辉瑞)一种乙酰胆碱酯酶抑制剂(AChEI)。“在一个胶囊里Namzaric组合两个互补疗效的药剂，通常共同规定大约70%使用盐酸美金刚的患者也使用AchEI的治疗”，阿特维斯全球品牌研发部门高级副总裁大卫•尼科尔森，在一次新闻发布会上指出。盐酸美金刚XR和多奈哌齐都证实了其疗效和安全性，用于治疗中度至重度的阿尔茨海默氏症患者。此外，数据显示，盐酸美金刚XR和AchEI的联合疗法对认知上显示了较大的改善，以及全功能的改善相对于单独使用AChEI”，尼克尔森表示。

Namzaric(先前MDX-8704)目前是每日一粒服用的胶囊剂，含有美金刚胺(10毫克每日两次或28毫克XR每日一次)再加上多奈哌齐10毫克。胶囊可以打开，撒在食物上用于有吞咽困难的病人服用。Namzaric可以采用两方面的特点:28/10毫克(美金刚/多奈哌齐)和14/10毫克(美金刚/多奈哌齐)用于有严重肾功能损害的患者。

“在对阿尔茨海默病的中度到重度的阶段病人做治疗决定时，我会考虑治疗的有效性、安全性及其易于管理的特点，”加州科斯塔梅萨ATP临床研究神经精神病学家和医学主任医学博士Gustavo Alva和加州大学志愿者教员欧文在新闻发布会上说。“FDA批准Namzaric提供新的治疗选择，这为病人提供了一个固定剂量组合的药剂，这种药剂在一个胶囊中实现了两种治疗效果”他补充道。

原始出处

Megan Brook. FDA OKs Memantine/Donepezil (Namzaric) Combo Pill for Alzheimer's Disease. December 26, 2014

本文是MedSci原创，转载请注明出处，非常感谢！

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2015-06-03 zhs3882

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2015-07-04 ms1948154235210413

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2015-12-19 shanyongle

#多奈哌齐#

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2015-07-18 柳叶一刀

#阿尔茨海#

28 0
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2015-04-09 chendoc242

#美金刚#

31 0
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2015-09-30 bugit

#FDA批准#

27 0
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2015-01-06 yhj-time

#阿尔茨海默#

25 0

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FDA批准美金刚胺/多奈哌齐(Namzaric)组合药剂用于治疗阿尔茨海默氏症

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