Mustafa Ahmaya A, Rajan Robin, Suarez Jennifer D, Alzghari Saeed K
School of Pharmacy, Texas Tech University Health Sciences Center, Amarillo, USA.
School of Pharmacy, Texas Tech University Health Sciences, Abilene, USA.
Cureus. 2018 Jun 20;10(6):e2844. doi: 10.7759/cureus.2844.
There is an undeniable opioid crisis in the United States that has caused significant negative consequences including many lives lost due to opioid overdoses. Currently, researchers are searching for alternatives for pain management as well as developing abuse-deterrent agents. In February 2018, the Food and Drug Administration (FDA) approved benzhydrocodone and acetaminophen (Apadaz™) for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and where alternative treatments are inadequate. This article looks further into this oral opioid prodrug and assesses its clinical pharmacology, pharmacokinetics, clinical trials and safety considerations that led to approval. Even though this prodrug provides a novel approach to analgesia, it was not classified as an abuse-deterrent agent and therefore still has the potential for abuse and misuse. This new agent potentially runs a higher risk of augmenting the opioid crisis rather than curtailing it. Innovative approaches to discover opioid alternatives are warranted.
美国存在一场不可否认的阿片类药物危机，已造成重大负面后果，包括许多人因阿片类药物过量死亡。目前，研究人员正在寻找疼痛管理的替代方法，并研发防止滥用的药物。2018年2月，美国食品药品监督管理局（FDA）批准了苯氢可酮和对乙酰氨基酚（Apadaz™）用于短期（不超过14天）管理严重到需要使用阿片类镇痛药且其他替代治疗方法不足的急性疼痛。本文将进一步探讨这种口服阿片类前体药物，并评估其临床药理学、药代动力学、临床试验以及促成其获批的安全性考量因素。尽管这种前体药物提供了一种新的镇痛方法，但它未被归类为防止滥用的药物，因此仍有被滥用和误用的可能性。这种新药有可能加剧而非缓解阿片类药物危机。有必要采取创新方法来寻找阿片类药物的替代品。
