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July 17, 2007


First Skin Patch To Treat Alzheimer's Approved In The US

The Swiss drug company Novartis announced today that its new product Exelon Patch has been approved by the US Food and Drug Administration (FDA) as the first skin patch for patients with mild to moderate Alzheimer's disease.

スイス製薬会社ノバルティスは、本日、新製品エクセロン パッチ剤が軽度から中等度のアルツハイマー型認知症患者ための初の皮膚パッチ(貼付)剤として米国食品医薬品局(FDA)の承認を得たと発表した。

Exelon Patch:エクセロン パッチ剤(経皮吸収型製剤)

The FDA also approved the product for the treatment of patients with mild to moderate Parkinson's disease dementia, a distinct and common disorder that affects 20 per cent of people diagnosed with Parkinson's.


distinct disorder :顕著な障害

Exelon Patch maintains steady bloodstream levels of the the drug rivastigmine (a cholinesterase inhibitor) for 24 hours via a transdermal patch that is applied to the back, chest or upper arm of the patient.

エクセロン パッチ剤は、背中、胸部または患者の上腕に貼付による経皮吸収型製剤介して24時間アルツハイマー病治療薬のリバスチグミン(コリンエステラーゼ阻害剤)の持続的な血流濃度を維持します。


This method extends the drug's tolerability and its effectiveness over a wider range of patients, some of whom may not be able to take the oral capsule version because of the increased prevalence of gastrointestinal side effects often seen with cholinesterase inhibitors.


cholinesterase inhibitors:コリンエステラーゼ阻害薬
gastrointestinal side effects:消化器系副作用

Novartis said that innovation wasn't just about developing new drugs but also about finding ways to deliver existing drugs in new ways to meet the needs of patients and caregivers.


The new therapy was tested in placebo-controlled clinical trials and improved Alzheimer patients' memory, ability to do everyday things and overall functioning. Also, compared with the oral capsule, the patch version resulted in three times fewer reported incidents of nausea and vomiting.


placebo-controlled clinical trials プラセボ対照臨床治験

The trial was called the international IDEAL (Investigation of Transdermal Exelon in ALzheimer's disease) clinical trial and involved nearly 1,200 patients with mild to moderate Alzheimer's disease. The efficacy of the patch version of Exelon was similar the highest doses of the capsule version, being well tolerated by patients in the target dose of 9.5 mg per 24 hours.


Investigation of Transdermal Exelon in ALzheimer's disease:アルツハイマー病におけるけい皮吸収剤エクセロンの調査

Novartis said the product should be available in US pharmacies soon. It was submitted for approval in the European Union late last year.


According to the clinical trial results, the patch was preferred by over 70 per cent of caregivers because it interfered less with their daily life, was easier to use and helped them follow the treatment schedule.


Approximately 18 million people worldwide have Alzheimer's, with more than 5 million of them in the US. This number is expected to reach 7.7 million by 2030.


Alzheimer's is a progressive degenerative disease of the brain that impairs memory, thinking and behaviour, robbing people of their ability to carry on with their everyday lives. It affects mostly people over 65 years old.


progressive degenerative disease 進行性変性疾患

Parkinson's is also a chronic, progressive neurological disorder that affects about 1.5 million people in the US, 20 per cent of whom have Parkinson's dementia, a distinct disorder that reduces memory, decision making, and attention.


Parkinson's dementia:パーキンソン病の認知障害
decision making 意思決定


以前ガン患者の疼痛管理のためのパッチ剤の話を聞く機会がありました。内服の鎮痛剤は消化器系に問題を起こすことが知られています。鎮痛剤を 処方されると必ず胃腸薬がついてきます。消化器系の障害を起こさないために疼痛管理にパッチ剤を使用して皮膚から有効成分を吸収させて効果を発揮すると聞きました。今回は、あるツハイマー病に関してのパッチ剤でした。







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