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Xtampza ER 即一种阿片类药物控释制剂,其具有防滥用特性,在治疗中心人群中进行的 Xtampza ER 篡改的横断面研究。

A Cross-Sectional Study of Tampering in Xtampza ER, an Abuse-Deterrent Formulation of an Extended-Release Opioid, in a Treatment Center Population.

机构信息

Rocky Mountain Poison and Drug Safety, Denver Health and Hospital Authority, 1391 Speer Blvd UNIT 600, Denver, CO, 80204, USA.

Department of Psychiatry, School of Medicine, Washington University in St. Louis, 660 S Euclid Ave, St. Louis, MO, 63110, USA.

出版信息

Clin Drug Investig. 2023 Mar;43(3):197-203. doi: 10.1007/s40261-023-01248-9. Epub 2023 Mar 1.

Abstract

BACKGROUND AND OBJECTIVE

While the current landscape of opioid use disorder (OUD) is complicated by the increase in use of non-prescription opioids, prescription opioids continue to be frequently used in non-medical ways. In response to this abuse, pharmaceutical companies have developed abuse deterrent formulations (ADFs) for extended-release (ER) opioids. To test the effectiveness of Xtampza ER ADF (oxycodone myristate) at reducing tampering, its rate of tampering in a treatment-center population was compared to immediate release (IR) single entity (SE) oxycodone, other ER oxycodone opioids, and ER oxymorphone.

METHODS

Data were collected between the third quarter of 2018 and the third quarter of 2021 from individuals entering nationally distributed opioid treatment programs. To determine odds of tampering with Xtampza ER compared to each comparator, a logistic model was fit with a random intercept allowing for multiple drugs in each subject. Within-subject correlation was assumed to have a compound symmetric relationship.

RESULTS

Overlap among the categories of drug tampering was high. Logistic regression analyses found that oxycodone myristate had lower odds of tampering when compared to both IR SE oxycodone (OR = 0.23 [95% CI 0.11, 0.50], p = 0.0002) and ER oxymorphone (OR = 0.30 [95% CI 0.14, 0.67], p = 0.0038). Oxycodone myristate was not significantly different from other ER oxycodone opioids (OR = 0.5 [95% CI 0.24, 1.03], p = 0.0612). These findings did not change when the estimates were adjusted for age and sex.

CONCLUSIONS

Drugs employing ADF technology may reduce the likelihood of tampering when compared to non-ADF formulations in a treatment-center population, which represents an opportunity for intervention in OUD among those still requiring pain management.

摘要

背景与目的

虽然目前阿片类药物使用障碍(OUD)的情况因非处方阿片类药物使用的增加而变得复杂,但处方类阿片类药物仍经常被非医疗方式使用。为了应对这种滥用,制药公司为延长释放(ER)阿片类药物开发了防滥用配方(ADF)。为了测试 Xtampza ER ADF(吗吲哚)在减少篡改方面的有效性,将其在治疗中心人群中的篡改率与即释(IR)单一实体(SE)羟考酮、其他 ER 羟考酮类药物和 ER 羟吗啡酮进行了比较。

方法

数据收集于 2018 年第三季度至 2021 年第三季度期间,来自进入全国分布的阿片类药物治疗项目的个体。为了确定与每个对照药物相比,Xtampza ER 发生篡改的几率,使用具有随机截距的逻辑模型进行拟合,允许每个个体使用多种药物。假设个体内相关性具有复合对称关系。

结果

药物篡改类别的重叠率很高。逻辑回归分析发现,与即释 SE 羟考酮(OR=0.23 [95% CI 0.11, 0.50],p=0.0002)和 ER 羟吗啡酮(OR=0.30 [95% CI 0.14, 0.67],p=0.0038)相比,羟考酮 myristate 发生篡改的几率较低。羟考酮 myristate 与其他 ER 羟考酮类药物(OR=0.5 [95% CI 0.24, 1.03],p=0.0612)无显著差异。当根据年龄和性别调整估计值时,这些发现没有改变。

结论

在治疗中心人群中,与非 ADF 制剂相比,采用 ADF 技术的药物可能会降低篡改的可能性,这为那些仍需要疼痛管理的 OUD 患者提供了干预机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9730/10049928/9e19b6ff5c37/40261_2023_1248_Fig1_HTML.jpg

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