药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201252101104221.pdf,201252101103635.pdf,201252101103134.pdf,201252101102810.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Bridon处方资料(仅供参考)
先灵葆雅制药公司近日宣布,欧盟已经批准sugammadex用于在术后逆转麻醉药物的肌松效果。sugammadex为注射剂,商品名为Bridon,主要用在术后逆转手术时使用全麻药物rocuronium或vecuronium诱导产生的神经肌肉阻滞效果。
Merck & Co confirms NDA filing for suvorexant in 2012 US drugs giant Merck & Co (NYSE: MRK) yesterday provided an update on the development program for suvorexant, the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia.
The two pivotal Phase III efficacy trials for suvorexant have been completed and, based on the positive results of these studies, Merck plans to file a New Drug Application for suvorexant with the US Food and Drug Administration during this year.
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Would join crowded market
Assuming suvorexant gains marketing approval, it would enter a US market sector valued at around $2.7 billion in 2010, but has been dominated by Sanofi’s Ambien (zolpidem), which is now off patent, and Eisai’s Lunesta (eszopiclone), as well as a range of cheaper generic medicines. However, insomnia affects as many as 70 million adults in the USA and up to 15% of them have chronic trouble falling asleep or staying asleep, according to the National Institute of Health’s Center for Sleep Disorders Research.
Merck notes that both Phase III studies were multicenter, randomized, double-blind, placebo-controlled clinical trials that evaluated suvorexant compared to placebo in adult patients aged 18 years and older. The primary endpoint was change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months. Merck plans to submit these data for presentation at major medical meetings later this year.
Suvorexant is one of the five major US filings Merck anticipates for 2012 and 2013. The others, the company announced at an R&D briefing last year, are: Tredaptive [ER niacin/laropiprant] (for atherosclerosis); odanacatib (for osteoporosis); V503 (a cervical cancer vaccine); and Bridon (sugammadex; for reversal of neuromuscular blockade; The Pharma Letter November 11, 2012).
"Suvorexant selectively targets an important pathway involved in helping to promote sleep and, if approved, will be a new, first-in-class treatment for patients with insomnia," said Peter Kim, president, Merck Research Laboratories, adding: "We are enthusiastic about the potential of this investigational medicine, and look forward to sharing the results from these studies with the medical community."
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