Acute migraine: novel therapy shows promise in Phase III trial

Written by Sharon Salt, Editor

A drug that belongs to a new generation of acute migraine treatments, termed rimegepant, has been demonstrated to eliminate pain and reduce bothersome symptoms for people with migraine in a randomized, double-blind, large-scale trial.
At present, many individuals with migraine take triptan drugs, which work by stimulating serotonin receptors to reduce inflammation and constrict blood vessels. However, triptans can produce intolerable side effects in some individuals, particularly those with cardiovascular disease or associated major risk factors. Thus, a new class of drugs that target CGRP receptors called gepants, which includes rimegepant, may be more beneficial.

In this new study, which has been published in The New England Journal of Medicine, researchers assessed rimegepant in more than 1000 men and women with migraine at 49 centers in the USA. The participants were randomly assigned to take either rimegepant or placebo during a migraine attack, once moderate or severe pain developed.

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Before taking the tablet and for 48 hours afterwards, participants answered questions in an electronic diary, which highlighted their pain and their most bothersome symptoms. These symptoms were chosen from a list, which included intolerance to light, intolerance to sounds or nausea.

After 2 hours from taking their tablets, 19.6% of individuals in the rimegepant group were free from pain compared with 12% in the placebo group. Freedom from their most bothersome symptoms occurred in 37.6% of participants in the rimegepant group and 25.2% in the placebo group. Side effects were reported to be minimal, with nausea and urinary tract infections being the only adverse events reported.

Richard Lipton (Montefiore Headache Center, NY, USA), first author of the study, concluded: “These results confirm that rimegepant’s mechanism of action – blocking the CGRP pathway – effectively relieves pain and associated symptoms that occur during acute migraine attacks. As someone who has studied CGRP blockers for more than a decade, I’m gratified to see their benefits confirmed in a large-scale clinical trial.”

Sources: Lipton RB, Croop R, Stock EG et al. Rimegepant, an oral calcitonin gene-related peptide receptor antagonist, for migraine. N. Engl. J. Med. 381, 142–149 (2019); www.einstein.yu.edu/news/1358/novel-therapy-for-acute-migraine-shows-promise-in-phase-3-clinical-trial/