Tyler Betty M, Guarnieri Michael
Department of Neurosurgery, Johns Hopkins University, 1550 Orleans Street, 1550 Orleans St. CRB II, Baltimore, MD 21287, USA.
Vet Sci. 2023 May 24;10(6):372. doi: 10.3390/vetsci10060372.
Long-acting injectable (LAI) opioid formulations mitigate the harm profiles and management challenges associated with providing effective analgesia for animals. A single dose of a long-acting opioid analgesic can provide up to 72 h of clinically relevant pain management. Yet, few of these new drugs have been translated to products for veterinary clinics. Regulatory pathways allow accelerated drug approvals for generic and biosimilar drugs. These pathways depend on rigorous evidence for drug safety and pharmacokinetic evidence demonstrating bioequivalence between the new and the legacy drug. This report reviews the animal PK data associated with lipid and polymer-bound buprenorphine LAI formulations. Buprenorphine is a widely used veterinary opioid analgesic. Because of its safety profile and regulatory status, buprenorphine is more accessible than morphine, methadone, and fentanyl. This review of PK studies coupled with the well-established safety profile of buprenorphine suggests that the accelerated approval pathways may be available for this new family of LAI veterinary pharmaceuticals.
长效注射用（LAI）阿片类药物制剂可减轻为动物提供有效镇痛相关的危害及管理挑战。单剂量长效阿片类镇痛药可提供长达72小时的临床相关疼痛管理。然而，这些新药中很少有转化为兽用诊所产品的。监管途径允许对仿制药和生物类似药进行加速药物审批。这些途径依赖于严格的药物安全性证据以及证明新药与原研药生物等效性的药代动力学证据。本报告回顾了与脂质和聚合物结合的丁丙诺啡LAI制剂相关的动物药代动力学数据。丁丙诺啡是一种广泛使用的兽用阿片类镇痛药。由于其安全性和监管地位，丁丙诺啡比吗啡、美沙酮和芬太尼更容易获得。对药代动力学研究的综述以及丁丙诺啡已确立的安全性表明，加速审批途径可能适用于这一新的LAI兽用药物家族。
