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

DOI: https://doi.org/10.1007/s40265-019-01225-7

Abstract-Summary In October 2019, the US FDA approved lasmiditan 50 mg and 100 mg tablets for the acute treatment of migraine with or without aura in adults.

Lasmiditan is not for use in the preventive treatment of migraine. This article summarizes the milestones in the development of lasmiditan leading

to its first approval for the acute treatment of migraine in adults.

Introduction Lasmiditan (REYVOW™) is an orally available, highly selective serotonin (5-HT)1F receptor agonist being developed by Eli Lilly and Company as an acute treatment for migraine [45, 46].

As per the terms of the agreement, CoLucid holds an exclusive worldwide license (including the right to grant sublicenses) under certain patents that Eli Lilly owns or controls for lasmiditan; Eli Lilly has retained the right to conduct research on lasmiditan (and products containing it) for the purposes of internal research only.

CoLucid must use reasonable commercial efforts to develop and obtain approval for selling products containing lasmiditan in all major markets (e.g. USA, United Kingdom, Japan) [47].

Lasmiditan was initially developed by Eli Lilly and Company utilizing a human clone of the 5-HT1F receptor discovered by Synaptic Pharmaceutical Corporation (now Lundbeck Research USA, after being acquired by and becoming a wholly owned subsidiary of Lundbeck A/S in March 2003).

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4 Treatment

Scientific Summary In SPARTAN, significantly higher proportions of lasmiditan recipients than placebo recipients achieved headache pain freedom (28.6%, 31.4% and 38.8% with lasmidi- tan 50 mg, 100 mg and 200 mg, respectively, vs 21.3% with placebo; p ≤ 0.003 for all comparisons) and MBS freedom (40.8%, 44.2% and 48.7% vs 33.5%; p ≤ 0.009 for all comparisons) at 2 h post-dose (primary efficacy objectives) [48].

In this subgroup, lasmiditan significantly improved the proportions of patients who were pain free (p < 0.05 for all doses vs placebo) and MBS free (p < 0.05 for all doses vs placebo) at 2 h. In the subgroup not using concomitant preventive medi- cations, lasmiditan also significantly improved the proportions of patients who were pain free (p < 0.05 for all doses vs placebo) and MBS free [p < 0.05 for lasmiditan 100  mg and 200  mg (but not 50 mg) vs placebo] at 2 h. Across SAMURAI and SPARTAN, 698/3981 patients concurrently used migraine preventive treat- ments [49].

Acknowledgement A machine generated summary based on the work of Lamb, Yvette N. 2019 in Drugs.

Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials