Epidemiologic Study of the Effectiveness of an ADF in Reducing Opioid Abuse

描述（由申请人提供）：本时间敏感性申请的总体目标是测量奥施康定（R）新型滥用威慑制剂（ADF）在减少奥施康定（R）滥用方面的有效性。处方阿片类药物滥用是一个主要的公共卫生问题，尤其困扰着美国农村地区。国家药物管制政策办公室（ONDCP）和FDA强烈鼓励制药行业开发防止滥用的配方;然而，除了在疼痛患者中进行的临床试验证明药物治疗疼痛的疗效外，迄今为止还没有流行病学研究检查ADF是否真的有效减少任何药物的滥用。一项关于处方阿片类药物滥用的纵向流行病学研究目前正在肯塔基州农村进行后期随访（R 01-DA 024598），其中94.8%的参与者在其一生中滥用奥施康定（R），81%的参与者在制剂变更前6个月内滥用该药物。鉴于在配方变更前奥施康定（R）滥用的高患病率，该研究样本是检测奥施康定（R）新ADF滥用信号变化的理想选择。具体目标包括：1）评价奥施康定（R）ADF在减少口服、鼻内和注射途径滥用方面的有效性; 2）确定一旦街上不再有非ADF版本的阿片类药物，阿片类药物使用者是否过渡到滥用其他处方阿片类药物;和3）检查艾滋病毒和丙型肝炎（HCV）的流行和发病率的变化由于旧制剂不再可用后给药途径发生变化。考虑到与ADF减少处方阿片类药物滥用的有效性相关的流行病学数据缺乏，这项时间敏感的研究非常重要。此外，本研究具有独特的优势，可快速测量ADF对奥施康定（R）的有效性，并且不会出现回顾性评估滥用时可能产生的潜在偏倚。鉴于ONDCP和FDA对进一步开发处方阿片类药物的ADF的重要性，这项研究的结果除了对公共卫生外，还对公共政策产生了巨大的影响。这项高度相关的研究将评价ADF模型在多个公共卫生领域的有效性，包括通过口服、鼻内和注射给药途径滥用和误用本品的变化。反过来，这项研究的结果将不仅对公共卫生产生巨大影响，而且对围绕开发ADF以防止滥用处方阿片类药物的阿索政策也产生巨大影响。

DESCRIPTION (provided by applicant): The overarching goal of this time-sensitive application is to measure the effectiveness of the new abuse deterrent formulation (ADF) for OxyContin(R) in decreasing abuse of OxyContin(R). Prescription opioid abuse is a major public health concern and has plagued the rural United States in particular. The Office of National Drug Control Policy (ONDCP) and the FDA have strongly encouraged the pharmaceutical industry to develop formulations that protect against abuse; however, apart from clinical trials among pain patients demonstrating efficacy of the drug for treating pain, there have been no epidemiologic studies to date that have examined whether ADFs are actually effective in reducing abuse of any drug. A longitudinal epidemiologic study of prescription opioid abuse is currently in the latter phase of follow-up in rural Kentucky (R01-DA024598) in which 94.8% of participants abused OxyContin(R) in their lifetime, and 81% abused the drug in the 6-months prior to the formulation change. Given this high prevalence of OxyContin(R) abuse before the formulation change, this study sample is ideal for detecting changes in signals of abuse with the new ADF for OxyContin(R). The specific aims include: 1) evaluation of the effectiveness of the ADF for OxyContin(R) in reducing abuse via oral, intranasal and injection routes; 2) determining whether opioid users transitioned to abuse of other prescription opioids once the non-ADF version was no longer available on the street; and 3) examination of changes in prevalence and incidence of HIV and hepatitis C (HCV) as a result of changes in route of administration after the old formulation was no longer available. This time-sensitive study is highly significant given the paucity of epidemiologic data related to the effectiveness of ADFs in reducing abuse of prescription opioids. Further, this study is uniquely positioned to measure the effectiveness of the ADF for OxyContin(R) expeditiously and without the potential bias that would result if abuse were assessed retrospectively. Given the importance that the ONDCP and the FDA have placed on further development of ADFs for prescription opioids, the results from this study have vast implications for public policy in addition to public health. This highly relevant study will evaluae the effectiveness of a model ADF across multiple public health domains, including changes in this product's abuse and misuse via the oral, intranasal and injection routes of administration. The results from this study, in turn, will have vast implications for not only public health, but aso policies surrounding development of ADFs in order to prevent abuse of prescription opioids.