氢可酮控释片：争议的药效学、药代动力学和行为药理学。

Hydrocodone extended-release: pharmacodynamics, pharmacokinetics and behavioral pharmacology of a controversy.

机构信息

Department of Neurology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Department of Anesthesiology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Neuroscience Center of Excellence, LSU Health Sciences Center, New Orleans, LA 70112, United States; Center of Excellence for Oral and Craniofacial Biology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Alcohol and Drug Abuse Center of Excellence, LSU Health Sciences Center, New Orleans, LA 70112, United States.

Department of Neurology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Department of Anesthesiology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Department of Pharmacology and Experimental Therapeutics, LSU Health Sciences Center, New Orleans, LA 70112, United States; Neuroscience Center of Excellence, LSU Health Sciences Center, New Orleans, LA 70112, United States; Center of Excellence for Oral and Craniofacial Biology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Alcohol and Drug Abuse Center of Excellence, LSU Health Sciences Center, New Orleans, LA 70112, United States.

出版信息

Pharmacol Res. 2015 Jan;91:99-103. doi: 10.1016/j.phrs.2014.09.006. Epub 2014 Oct 6.

DOI:10.1016/j.phrs.2014.09.006

PMID:25301538

Abstract

Recently, the U.S. Food and Drug Administration (FDA) approved Zohydro(®), an extended release formulation of the opioid analgesic hydrocodone that contains no acetaminophen. This approval was against the recommendation of the FDA's Expert Panel. Subsequently, both chronic pain advocates and anti-drug abuse advocates have steadfastly expressed their support of, or astonishment at this decision. Here, we review the pharmacokinetics, pharmacodynamics, safety and abuse liability of this hydrocodone formulation and how it relates to the Expert Panel's opinion and the FDA decision. We discuss the important issues, risk mitigation, potential use of abuse deterrents, and how the different viewpoints of the Expert Panel and FDA decision makers resulted in the approval and subsequent controversy.

摘要

最近，美国食品和药物管理局（FDA）批准了 Zohydro ®，这是一种含有非乙酰氨基酚的阿片类镇痛药氢可酮的缓释制剂。这一批准违背了 FDA 专家小组的建议。随后，慢性疼痛倡导者和反毒品滥用倡导者都坚决表示支持或对这一决定感到惊讶。在这里，我们回顾了这种氢可酮制剂的药代动力学、药效学、安全性和滥用倾向以及它与专家小组的意见和 FDA 决定的关系。我们讨论了重要问题、风险缓解、滥用抑制剂的潜在用途，以及专家小组和 FDA 决策者的不同观点如何导致了批准和随后的争议。