Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2020 May;80(7):741-746. doi: 10.1007/s40265-020-01301-3.
The orally disintegrating tablet (ODT) formulation of rimegepant (NURTEC ODT) is a small molecule, highly-selective, calcitonin gene-related peptide antagonist that was developed by Biohaven Pharmaceutical Holding Company Ltd as an acute treatment for migraine. A conventional tablet formulation of the drug is being investigated for the acute treatment (under FDA review in the USA) and prevention of migraine and the treatment of refractory trigeminal neuralgia. In February 2020, rimegepant ODT received its first global approval in the USA for the acute treatment of migraine (± aura) in adults. This article summarizes the milestones in the development of rimegepant leading to its first global approval for acute treatment of migraine (± aura) in adults.
利马喷丁(NURTEC ODT)的口崩片(ODT)制剂是一种小分子、高选择性的降钙素基因相关肽拮抗剂,由佰昊健生物医药有限公司开发,作为偏头痛的急性治疗药物。该药的常规片剂制剂正在进行急性治疗(美国 FDA 审查中)和偏头痛预防以及难治性三叉神经痛的治疗研究。2020 年 2 月,利马喷丁 ODT 在美国获得首个全球批准,用于成人偏头痛(伴或不伴先兆)的急性治疗。本文总结了利马喷丁开发过程中的重要里程碑,最终使其获得首个全球批准,用于成人偏头痛(伴或不伴先兆)的急性治疗。