Chiang Chia-Chun, VanderPluym Juliana H
Department of Neurology, Mayo Clinic, Rochester, MN, USA.
Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.
J Pain Res. 2021 Apr 27;14:1185-1192. doi: 10.2147/JPR.S244249. eCollection 2021.
Ubrogepant is a small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist that received Food and Drug Administration (FDA) approval for the acute treatment of migraine with and without aura in adults. The ACHIEVE I and ACHIEVE II Phase III clinical trials showed that ubrogepant was superior to placebo for pain freedom and freedom of the most bothersome migraine-associated symptom at 2 hours after medication intake. The 52-week open label extension of the Phase III trials demonstrated safety of ubrogepant. A real-world study conducted at a tertiary headache center also confirmed the efficacy and safety of ubrogepant. Adverse event rates were higher in the real-world population. Studies are needed to evaluate its long-term efficacy and safety, especially in the setting of co-administration with other CGRP modulating therapies such as the CGRP monoclonal antibodies.
ubrogepant是一种小分子降钙素基因相关肽（CGRP）受体拮抗剂，已获得美国食品药品监督管理局（FDA）批准，用于成人有先兆和无先兆偏头痛的急性治疗。ACHIEVE I和ACHIEVE II III期临床试验表明，ubrogepant在服药后2小时实现疼痛缓解以及缓解最困扰的偏头痛相关症状方面优于安慰剂。III期试验的52周开放标签扩展试验证明了ubrogepant的安全性。在一家三级头痛中心进行的一项真实世界研究也证实了ubrogepant的有效性和安全性。真实世界人群中的不良事件发生率更高。需要开展研究以评估其长期疗效和安全性，尤其是在与其他CGRP调节疗法（如CGRP单克隆抗体）联合使用的情况下。
