2013年9月12日訊 /生物谷BIOON/ --安斯泰來(Astellas)和日本Toa Eiyo公司9月10日宣布,在日本推出Bisono Tape 4mg和Bisono Tape 8mg(合併簡稱Bisono Tape,非專有名稱:比索洛爾,bisoprolol),這是全球首個β1受體阻滯劑透皮貼片,用於輕度至中度原發性高血壓患者的治療。
Bisono Tape由Toa Eiyo和日東電工(Nitto Denko)聯合開發,是一種透皮吸收型高血壓治療藥物,含4mg或8mgβ1選擇性阻斷劑比索洛兒(bisoprolol),該藥是全球首個β1受體阻滯劑透皮貼片,同時也是日本首個高血壓透皮治療藥物。
Bisono Tape一天一次粘於胸部、上臂部或背部中的任一部位,每24小時重新粘帖一次,為高血壓患者提供了一個新的治療選擇。
Bisono Tape的特點如下:
●適用於不適合經口給藥的原發性高血壓病患者(輕度至中度病例)。
●每天給藥一次可以維持長達24小時持續穩定的降壓效果。
●可以目測確認是否給藥,輕鬆避免忘記服藥和過量給藥的風險,從而改善患者依從性。
日本國內的第Ⅲ期臨床試驗結果顯示,針對日本人的原發性高血壓病(輕度~中度)患者,Bisono Tape能持續維持充分的降壓效果長達24小時。且就安全性而言,去除粘帖部位的副作用以外,其他副作用的發生頻度與其他經口給藥的β1受體阻滯劑相當。
【注】β1受體阻滯劑是指,能選擇性地對交感神經腎上腺素能受體中,主要分布於心肌及腎臟的β1腎上腺素受體表現出阻滯作用的一種藥物類型。通過減少心輸出量,抑制交感神經末梢去甲腎上腺素的釋放,以及抑制腎小球旁細胞血管緊張素的分泌等作用達到降低血壓的效果。
英文原文:Launch of Bisono? Tape in Japan, Transdermal Patch of β1 Blocker, for The First Time in The World
Toa Eiyo Ltd. (Tokyo; Unlisted; 「Toa Eiyo」) and Astellas Pharma Inc. (Tokyo: 4503; 「Astellas」) announced today that, on September 10, 2013, Toa Eiyo and Astellas will launch Bisono? Tape 4 mg and Bisono? Tape 8 mg (collectively, 「Bisono? Tape」, nonproprietary name: bisoprolol), a transdermal patch of β1 blocker for the first time in the world.
Bisono? Tape, co-developed by Toa Eiyo and Nitto Denko Corporation, is a transdermal medication which contains 4 mg or 8 mg of bisoprolol, a β1 selective blocking agent, and is the world’s first transdermal patch of β1 blocker and the first transdermal hypertension medication in Japan.
Bisono? Tape has the following characteristics:
1. Hypertension* medicine in tape provides a new choice.
It is a transdermal patch of β1 blocker for the first time in the world.
*The indication of Bisono? Tape is essential hypertension (mild to moderate cases).
2. Antihypertensive effect for 24 hours.
Build up of blood concentration is gentle and provides antihypertensive effect for 24 hours through once-daily administration.
3. Dose-dependently controls blood pressure. Effective for 52 weeks.
Bisono? Tape is available in 4 mg and 8 mg and the dose-dependent antihypertensive effect provides favorable blood pressure control for long periods.
4. Visible tape supports continuation of treatment.
The tape supports the continuation of treatment of patients with aspiration concerns and difficulties in maintaining medical compliance. It is also expected to improve medication adherance.
5. The main side-effects found in clinical trials in Japan were itchiness, dermatitis and erythema of applied region, and so on. Clinical trial abnormal value changes were blood triglyceride increase, ALT (GPT) increase, blood uric acid increase and eosinophil percentage increase, and so on.
Toa Eiyo is the marketing approval holder, Astellas will distribute and sell the prcoduct, and both companies will promote it.