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FDA批准帕金森病治疗新药沙芬酰胺

FDA approves safinamide to treat Parkinson’s disease
来源:Frontline Medical News 2017-04-18 10:10点击次数:1330发表评论

美国FDA于3月21日批准了沙芬酰胺(safinamide)作为附加治疗药物,用于正在服用左旋多巴/卡比多巴且经历“关期”的帕金森病患者。


The U.S. Food and Drug Administration approved safinamide tablets on March 21 as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.


Newron制药公司将以商品名Xadago上市销售沙芬酰胺。


Newron Pharmaceuticals will market safinamide under the brand name Xadago.


沙芬酰胺获批的部分证据来自纳入645例和549例服用左旋多巴并经历“关期”受试者的两项临床试验。与服用安慰剂的患者相比,服用沙芬酰胺的患者可经历更长且有益的“开期”。“开期”时间延长的同时,“关期”时间减少,且“开期”运动功能评价得分提高。“开期”是指帕金森病症状减轻,运动障碍消失的一段时间,而“关期”是指患者用药疗效不佳,导致诸如震颤和行走困难等帕金森病症状增加的一段时间。


Part of the evidence base for approving safinamide came from two clinical trials with 645 and 549 participants who were also taking levodopa and were experiencing “off” time. Patients who were receiving safinamide experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without dyskinesia, compared with those receiving a placebo. An “off” episode is when a patient’s medications are not working sufficiently, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. The increase in “on” time occurred with a reduction in “off” time and better scores on a measure of motor function during “on” time.


服用沙芬酰胺的患者最常见的不良反应包括不受控制的不自主运动、跌倒、恶心和失眠。


The most common adverse reactions observed in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and insomnia.


FDA在批准公告中指出,严重肝病患者、正在服用右美沙芬或单胺氧化酶抑制剂(MAO)(两种药物同服可导致血压急剧升高)的患者应禁止服用沙芬酰胺。沙芬酰胺还禁用于服用阿片类药物、圣约翰草制剂、某些抗抑郁药(如5-羟色胺去甲肾上腺素再摄取抑制剂、三环类、四环类及三唑吡啶类药物)或环苯扎林(可导致危及生命的5-羟色胺综合征)的患者。


In its announcement of the approval, the FDA noted that patients should not take safinamide if they have severe liver problems, take dextromethorphan, or take a monoamine oxidase inhibitor, because the two together may cause a sudden severe increase in blood pressure. Safinamide also should not be taken by patients who use a opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.


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学科代码: 神经病学     关键词:沙芬酰胺 帕金森病 FDA 新药 ,新闻 爱思唯尔医学网, Elseviermed
来源: Frontline Medical News
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