Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial
RCT (n=1772 with 4–14 migraine days per month [MDPM]) found small reduction in MDPM with atogepant 10mg OD(-4.0), 30mg OD (-3.8), 60mg OD (-3.6), 30mg BD (-4.2) and 60mg BD (-4.1) compared to placebo (-2.9;p<0.05 all comparisons). Nausea & fatigue were most commonly reported ADRs
Source:
The Lancet Neurology
SPS commentary:
A related commentary discusses the implications of this study of an orally administered, small-molecule, calcitonin gene-related peptide(CGRP) receptor antagonist and highlights that, given the wide variability of anti-CGRP and anti-CGRP receptor drugs that are now available, with different half-lives, the gepants could almost be considered to form a continuum between acute and prophylactic migraine treatment. This concept would be a departure from the distinction between acute and prophylactic treatment of migraine, and might help to address the fact that regular overuse of acutely acting drugs can induce medication-overuse headache. If future studies confirm that gepants can be used in this way, the availability of more drugs that meet individual needs will provide a substantial improvement for migraine patients.