Haddox J David
Vice President, Health Policy, Purdue Pharma L.P., One Stamford Forum, Stamford, Connecticut; Adjunct Associate Professor, Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.
J Opioid Manag. 2017 Nov/Dec;13(6):397-413. doi: 10.5055/jom.2017.0417.
Three concurrent public health problems coexist in the United States: endemic nonmedical use/misuse of opioid analgesics, epidemic overdose fatalities involving opioid analgesics, and endemic chronic pain in adults. These intertwined issues comprise an opioid crisis that has spurred the development of formulations of opioids with abuse-deterrent properties and label claims (OADP). To reduce abuse and misuse of prescription opioids, the federal Food and Drug Administration (FDA) has issued a formal Guidance to drug developers that delineates four categories of testing to generate data sufficient for a description of a product's abuse-deterrent properties, along with associated claims, in its Full Prescribing Information (FPI). This article reviews the epidemiology of the crisis as background for the development of OADP, summarizes the FDA Guidance for Industry regarding abuse-deterrent technologies, and provides an overview of some technologies that are currently employed or are under study for incorporation into OADP. Such technologies include physical and chemical barriers to abuse, combined formulations of opioid agonists and antagonists, inclusion of aversive agents, use of delivery systems that deter abuse, development of new molecular entities and prodrugs, and formulation of products that include some combination of these approaches. Opioids employing these novel technologies are one part of a comprehensive intervention strategy that can deter abuse of prescription opioid analgesics without creating barriers to the safe use of prescription opioids. The maximal public health contribution of OADP will probably occur only when all opioids have FDA-recognized abuse-deterrent properties and label claims.
阿片类镇痛药的非医疗使用/滥用流行、涉及阿片类镇痛药的过量用药致死流行以及成年人的慢性疼痛流行。这些相互交织的问题构成了一场阿片类药物危机，促使了具有滥用威慑特性和标签声明（OADP）的阿片类药物制剂的开发。为减少处方阿片类药物的滥用，美国联邦食品药品监督管理局（FDA）已向药物研发人员发布了一份正式指南，该指南划定了四类测试，以生成足以在完整处方信息（FPI）中描述产品滥用威慑特性及相关声明的数据。本文回顾了这场危机的流行病学情况，作为OADP开发的背景，总结了FDA关于滥用威慑技术的行业指南，并概述了一些目前已在使用或正在研究以纳入OADP的技术。此类技术包括防止滥用的物理和化学屏障、阿片类激动剂和拮抗剂的复方制剂、加入厌恶剂、使用防止滥用的给药系统、开发新的分子实体和前体药物，以及包含这些方法某种组合的产品配方。采用这些新技术的阿片类药物是全面干预策略的一部分，该策略可以防止处方阿片类镇痛药的滥用，同时不会对处方阿片类药物的安全使用造成障碍。只有当所有阿片类药物都具有FDA认可的滥用威慑特性和标签声明时，OADP对公共卫生的最大贡献才可能实现。
