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对阿片类药物滥用威配方的营销后研究:叙述性审查

Lynn Webster¹, Jeff Gudin², Jody L Green³

¹Dr. Vince Clinical Research, Overland Park, KS, USA.

Journal of pain research

|August 14, 2025

概括

阿片类药物滥用威剂 (ADFs) 在减少滥用方面表现有前途,但它们在现实世界中的影响仍然不清楚. 进一步的营销后研究对于了解这些疼痛管理选择的有效性至关重要.

科学领域:

药理学药理学是指药理学的学科.
公共卫生公共卫生
药物开发药物开发

背景情况:

处方阿片类止痛药由于对滥用和滥用的担忧而面临有限的可用性.
片滥用威剂 (ADFs) 的配方被开发出来,以抵御改,同时保持镇痛效果.
美国食品和药物管理局 (FDA) 根据临床前,药物动力学和临床证据对ADF的批准进行了分类.

研究的目的:

审查ADF在疼痛管理中的好处和必要性.
概述FDA对ADF的指导方针,强调营销后评估 (类别4).
总结目前可用的美国ADF处方阿片类药物的营销后研究.

主要方法:

进行了关于阿片类ADFs的现有文献的叙事审查.
通过PubMed搜索和引用跟踪识别了关键的营销后出版物.
专注于四种ADF:XTAMPZA ER,OXYCONTIN,HYSINGLA ER和ROXYBOND. 这四种ADF的治疗方法包括:

主要成果:

三种ADF (XTAMPZA ER,OXYCONTIN,HYSINGLA ER) 已经报告了营销后的研究.
这些研究通常表明,与非ADF或其他ADF相比,非口服滥用或滥用减少了.
尽管处方增加了,但XTAMPZA ER的非口服滥用/滥用水平持续较低.

结论:

药物对滥用,滥用和临床结果的整体影响需要进一步调查.
目前的ADF都没有在市场推广后的研究中获得FDA的第4类标签.
对于HYSINGLA ER和ROXYBOND,特别需要进行额外的营销后研究.

关键词:

ADF类别的类别是ADF类别.这种药物是Hydrocodone.氧化的氧化是什么?营销后的研究研究.

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