Within the 48-h period postdose, 107 of 954 (11.5%) ubrogepant-treated (50 mg dose) patients and 113 of 984 (11.2%) placebo recipients experienced ≥1 treatment- emergent adverse event (TEAE), with no serious TEAEs reported in either group during this 48-h period (pooled ACHIEVE data; abstract) [40].

Acknowledgement A machine generated summary based on the work of Scott, Lesley J. 2020 in Drugs.

Rimegepant: First Approval

DOI: https://doi.org/10.1007/s40265-020-01301-3

Abstract-Summary 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.

Introduction Rimegepant (NURTEC ODT®), the orally disintegrating tablet (ODT) formulation of the drug, is a small molecule, CGRP receptor antagonist developed by Biohaven Pharmaceutical Holding Company Ltd. for the treatment of migraine.

In 2016, Biohaven Pharmaceutical Holding Company Ltd entered into an exclu- sive, worldwide license agreement with Bristol-Myers Squibb for the development and commercialization of rimegepant, as well as other CGRP-related intellectual property [41].

Biohaven also entered into an exclusive worldwide license agreement with Catalent UK Swindon Zydis Limited (a subsidiary of Catalent Inc.) to provide Zydis® ODT fast-dissolving formulation technology for use in the development of rimegepant.

The agreement also provides exclusive rights for developing small molecule

CGRP receptor antagonists with the Zydis ODT technology [42].

In 2018, Biohaven Pharmaceutical Holding Company Ltd formed a wholly owned subsidiary, BioShin™, to develop and commercialize its late-stage migraine and neurology products, including rimegepant, in China and other Asia–Pacific markets [43].

4.1 Acute Treatment

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Scientific Summary In the pivotal randomized, double-blind, multicentre phase III trial, a single 75 mg dose of rimegepant ODT provided superior efficacy to placebo for the acute treat- ment of migraine in adults (aged ≥18  years) with moderate to severe headache pain [44].

In the NCT03237845 phase III trial, at 2 h post dose, a significantly (p < 0.001) higher percentage of patients in the rimegepant (n = 537 mITT) than placebo (n = 535) group achieved headache pain freedom (19.6 vs 12.0%) and MBS freedom (37.6 vs 25.2%) [coprimary endpoints].

In the NCT03235479 phase III trial, for the coprimary endpoints, a significantly (p < 0.03) higher percentage of rimegepant (n = 543 mITT) than placebo (n = 541) recipients achieved headache pain freedom (19.2 vs 14.2%) and MBS freedom (36.6 vs 27.7%) at 2 h post dose.

Acknowledgement A machine generated summary based on the work of Scott, Lesley J. 2020 in Drugs.

Lasmiditan: First Approval