Eerdekens Mariëlle, Radic Tatjana, Sohns Melanie, Khalil Feras, Bulawa Beata, Elling Christian
Grünenthal GmbH, Aachen, Germany.
J Pain Res. 2021 Jan 29;14:249-261. doi: 10.2147/JPR.S290487. eCollection 2021.
The opioid analgesic tapentadol was the first pain medication to be developed for the treatment of pain in children under a formal process established by the regulatory authorities. This article summarizes the outcomes of the pediatric development program for tapentadol across the entire age range from birth (including neonates) to adolescents <18 years of age. In addition, the challenges experienced when designing and conducting the pediatric tapentadol clinical trials as well as the interactions with the regulatory authorities are discussed. As a first outcome, the oral solution of tapentadol was authorized in the EU in 2018 as a new treatment option in the hospital setting for moderate to severe acute pain in children from 2 to <18 years of age.
阿片类镇痛药曲马多是首个根据监管机构制定的正式程序研发用于治疗儿童疼痛的止痛药物。本文总结了曲马多在从出生(包括新生儿)到18岁以下青少年的全年龄段儿科研发项目的成果。此外,还讨论了设计和开展曲马多儿科临床试验时遇到的挑战以及与监管机构的互动情况。作为首个成果,曲马多口服溶液于2018年在欧盟获批,作为一种新的治疗选择,用于治疗2至18岁儿童的中重度急性疼痛。