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.
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