A tale of 2 ADFs: differences in the effectiveness of abuse-deterrent formulations of oxymorphone and oxycodone extended-release drugs
A tale of 2 ADFs: differences in the effectiveness of abuse-deterrent formulations of oxymorphone and oxycodone extended-release drugs
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DOI：
10.1097/j.pain.0000000000000511
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发表时间：
2016-06-01
期刊：
影响因子：
7.4
通讯作者：
Kasper, Zachary A.
中科院分区：
文献类型：
--
作者：
Cicero, Theodore J.;Ellis, Matthew S.;Kasper, Zachary A.
延长释放类阿片镇痛剂的引入帮助引发了美国处方类阿片滥用的流行。为了使通过粉碎或溶解更难获得药物，奥施康定（Purdue Pharma，斯坦福德，CT）和Opana ER（Endo Pharmaceuticals Inc.，马尔文，宾夕法尼亚州），使用相同的基础技术（Intac，Grunenthal，亚琛，德国），分别在2010年和2012年推出。为了检查它们的相对有效性，我们对12，124名接受阿片类药物使用障碍治疗的人进行了结构化调查，然后使用结构化和开放式问题对这些患者的子集（N = 129）进行了更集中的在线调查。数据显示，奥施康定ADF在减少非口服滥用方面非常有效（ADF前为91.4%，ADF后为47.9%），特别是在吹入（78%-28.8%）和静脉注射活性药物（42.7%-21.4%）时。然而，尽管Opana ER ADF在减少吹入（80%-37.1%）、注射（60.0%-51.4%）和总体非口服滥用（94.3%-77.1%）方面有效，但随着时间的推移，未显示出显著降低。考虑到Opana ER样本量小于奥施康定样本量，我们的结果表明ADF的引入导致了不同的结果，这可能表明ADF的有效性可能具有药物特异性。考虑到处方阿片类药物对公共卫生的影响，以及开发ADF作为部分解决方案所付出的巨大努力，我们的初步研究表明，即使使用相同的专有技术，也必须对每种ADF进行评估。
The introduction of extended-release opioid analgesics helped initiate an epidemic of prescription opioid abuse in the United States. To make access to the drug by crushing or dissolution more difficult, abuse-deterrent formulations (ADFs) of OxyContin (Purdue Pharma, Stamford, CT) and Opana ER (Endo Pharmaceuticals Inc., Malvern, PA), which use the same foundation technology (Intac, Grunenthal, Aachen, Germany), were introduced in 2010 and 2012, respectively. To examine their relative effectiveness, we used a structured survey of 12,124 individuals entering treatment for opioid use disorder followed by a more focused online survey with a subset of these patients (N = 129) using both structured and open-ended questions. Data showed that the OxyContin ADF was highly effective in reducing nonoral abuse (91.4% before the ADF, 47.9% afterwards), particularly with insufflation (78%-28.8%) and intravenous injection of the active drug (42.7%-21.4%). However, although the Opana ER ADF was effective in reducing insufflation (80%-37.1%), injection (60.0%-51.4%), and overall nonoral abuse (94.3%-77.1%), it showed no significant decrease over time. Bearing in mind that the Opana ER sample was smaller in size than that for OxyContin, our results nonetheless suggest disparate outcomes resulting from the introduction of the ADFs, which could indicate that an ADF's effectiveness may be drug-specific. Given the public health impact of prescription opioids and the considerable effort being expended to develop ADFs as a partial solution to the problem, our preliminary studies suggest that each ADF must be evaluated on its own merits even if the same proprietary technology is used.