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出自识林

2016-02-11 识林

在美国，阿片类药物滥用导致的死亡人数一直在迅速上升。2014年阿片类药物导致了惊人的28,648人死亡，超过了道路交通事故死亡人数。阿片类滥用现在是美国年轻人最大的单一杀手，虽然各年龄组均受到阿片滥用的影响。阿片类药物引起的死亡迅速上升，并影响美国农村和城市各地，已成为一个全面爆发的危机。

处方阿片类药物和海洛因和最近非法芬太尼和芬太尼衍生物的滥用是滥用问题的主要原因。非法芬太尼的滥用尤其危险，因为芬太尼的效力是其它常见阿片类药物的100倍，重要的是逆转芬太尼过量比起逆转其它阿片类药物过量需要更多纳洛酮。（纳洛酮可以从受体上置换阿片类药物，因为其结合力更强，但芬太尼的结合力也很强。）鼻腔喷雾给药纳洛酮在美国已经广泛配备给救护车和警察人员，使他们能够在疑似阿片类药物过量的情况下不需要等待医疗帮助直接给予纳洛酮。然而，这在芬太尼过量的情况下可能不会有效，显然非法阿片类药物的供应商正在增加，甚至用芬太尼代替海洛因。

Obama总统在他最近的向国会发表的国情咨文中表示着手解决阿片滥用问题，在2月9日发布的2017财年预算提案中，他申请额外11亿美元用于对抗这一问题。FDA一直与滥用问题保持距离， 表示其角色是审评和批准安全有效的药品。FDA对发布关于遏制滥用剂型的指南一直行动缓慢，可能因为在这个领域没有什么历史，FDA打算解决滥用和非标签使用问题。国会已经对FDA不耐烦，对FDA的批评在Zohydro ER批准后达到高潮，Zohydro ER是一种没有遏制滥用功能的氢可酮缓释剂型。FDA几天前发布了一份新闻稿似乎标志着他们对遏制阿片滥用方式的变化。新闻稿中文编译请见【识林资讯 - FDA阿片类药物行动计划】。其中FDA表示现在将：

• 重新审视阿片类药物的“风险收益模式”，确保FDA考虑“更为广泛的公众健康影响。翻译过来就是，我们将不会批准更多Zohydro ER。
• 制定速释阿片类标签的变更。迄今为止这些产品大部分排除在对ER产品标签采取的措施之外。
• 扩大获得和鼓励研制阿片类产品遏制滥用配方。

这份新闻稿来自于FDA高层而不是CDER，表示在FDA对其工作“仅关注安全性和有效性”的显著变化。这可能不是结束，而是帮助预防更广泛的处方药滥用的配方属性的开始。

点评：识林-Pepper
编译：识林－椒
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英文原文

The Opioid Epidemic
Dr. Pepper |Feb 9, 2016

Deaths from opioid abuse have been rising rapidly in the US. In 2014 opioids were responsible for a staggering 28,648 deaths surpassing the number of deaths from road accidents. Opioid abuse is now the biggest single killer of young people in the US, although all age groups are affected by opioid abuse. Opioid induced death has risen rapidly and affects all parts of the US, rural as well as urban communities. It has become a full blown crisis.

The abuse of prescription opioids and of heroin and lately illicit fentanyl and fentanyl derivatives is the main cause of the abuse problems. The abuse of illicit fentanyl is particularly dangerous as fentanyl is about 100 times more powerful than other common opioids and importantly reversing fentanyl overdoses requires much more naloxone than for other opioid overdose reversal. (The naloxone displaces the opioid from the receptor as it binds more strongly but fentanyl binds strongly too.) Nasal spray administered naloxone has been distributed widely in the US to ambulance and police personnel to enable them to administer naloxone in suspected opioid overdose cases without the need to wait for medical help. However, this may not be effective in the case of fentanyl induced overdose and apparently suppliers of illicit opioids are adding or even substituting fentanyl for heroin.

President Obama addressed the problem of opioid abuse in his recent State of the Nation Address to Congress and in his budget proposal released today has asked for an additional $1.1 billion to fight this problem. FDA has maintained distance from the abuse issues stating that its role is the review and approval of safe and effective drug products. It has been slow to issue guidance on abuse deterrent dosage forms, probably because it has no history in this field and it is intended to address abuse and not labeled use by patients. Congress has become impatient with FDA, and criticism of the Agency came to a head with the approval of Zohydro ER, an extended-release form of hydrocodone which had no abuse deterrent features. FDA released a press release a few days ago which seems to mark a change in their approach to opioid abuse. You can read the release at the link below. Among other things it says FDA will now:

• Reexamine the “risk-benefit paradigm” for opioids to ensure that they consider “wider public health effects”. Translation, we won't approve any more Zohydro ERs.
• Develop changes for immediate-release opioid labeling. To date these products had been largely excluded from the measures taken in labeling for ER products.
• Expand access to and encourage the development of abuse deterrent formulations of opioid products.

This press release came from higher up in FDA than CDER and represents a significant change in FDAs “safety and efficacy only” approach to it's work. It may not be the end but rather the start of formulation properties to help prevent wider prescription drug abuse.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm484765.htm