bothersome symptom for more than one-third of participants within two hours, researchers reported at the 2019 American Headache Society Annual Meeting. The New England Journal of Medicine simultaneously published the study results.
Rimegepant is an oral calcitonin gene-related peptide (CGRP) antagonist currently in development for both treatment of acute migraine and migraine prevention. “Gepants” have demonstrated effectiveness in acute migraine in previous trials and do not have vasoconstrictive effects, unlike triptans, the current first-line treatment for acute migraine.
White tablet. Source: Getty
The multicenter, double blind, phase 3 trial enrolled 1186 patients who had suffered migraines for at least one year and experienced between two and eight moderate or severe migraine attacks each month. Participants had a mean age of 40.2 years and 88.75 were female. Participants were randomly assigned to 75 mg of rimegepant or placebo.
Patients self-administered a tablet of rimegepant or placebo during a moderate or severe migraine attack, after entering information about their pain and symptoms in an electronic diary. They assessed pain intensity, symptoms, and functional disability at 2, 3, 4, 6, 8, 24 and 48 hours after the dose.
At two hours, 19.6% of those who took rimegepant and 12% of patients who took placebo reported being pain-free, while 58.1% and 42.8% noted pain relief within the time period. At the same point, 37.6% in the rimegepant arm said they were free of their most bothersome symptom compared to 25.2% of those in placebo arm.
"The results of the Phase 3 study of rimegepant Zydis ODT for the acute treatment of migraine demonstrate the meaningful benefits of this easy-to-use single-dose formulation, with early and sustained relief of symptoms, low use of rescue medications, and low rates of adverse events," said study presenter Richard Lipton, MD, professor and vice chair of Neurology at the Albert Einstein College of Medicine. "A new effective, safe, and convenient acute treatment option would be a great advancement for the millions of people around the world whose daily lives are impacted by migraine."