Study: Rimegepant Effective for Preventative Migraine Treatment

Results of a study recently published in The Lancet showed that rimegepant (Nurtec ODT; Biohaven Pharmaceutical Holding Company) was effective as a preventative treatment of migraines.¹

Investigators observed that about half of patients treated with rimegepant showed a 50% or greater reduction in how many moderate-to-severe migraine days they experienced per month.²

Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist used to treat migraines by reversibly blocking CGRP receptors and stopping activity from the CGRP neuropeptide.^1,2 The drug is approved by the FDA for the acute treatment of migraine in adults.

Migraine is the second leading cause of disability and is the source of more disability than all other neurologic disorders combined.³ The disorder affects an estimated 1 billion individuals globally, primarily women. Migraine also affects approximately 1 in 6 Americans.

The US based, multicenter, phase 2/3, randomized, double-blind, placebo-controlled trial included 747 participants, of whom investigators randomly assigned to either rimegepant 75 mg (n=373) or placebo 75 mg (n=374) every other day for 12 weeks.1 Rimegepant demonstrated superior efficacy compared with placebo in regard to the primary end point: change in the mean number of migraine days per month during weeks 9 to 12 of the study.

Investigators reported a change of -4.3 (95% CI -4.8 to -3.9) in the mean number of days per month in the rimegepant group and -3.5 days ( -4.0 to -3.0) in the placebo group.

The most common adverse events (AEs) were nausea (2% in participants receiving rimegepant and 0.5% in those receiving placebo) and hypersensitivity, including dyspnea and rash, occurring in less than 1% of patients treated with rimegepant.²

Richard B. Lipton, MD, study co-author, professor and vice chair of neurology at the Albert Einstein College of Medicine and Montefiore Health System, director of the Montefiore Headache Center, said in a statement, "Migraine is a prevalent and debilitating disease, affecting roughly 1 in 6 Americans, and many are not helped by current treatments. The results published in The Lancet demonstrate the significant clinical benefits of rimegepant for the preventive treatment of migraine. These data show the promise of a new approach to preventive treatment with an oral CGRP antagonist."²

References

1. Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventative treatment of migraine: a phase 2/3, randomized, double-blind, placebo-controlled trial. The Lancet; December 15, 2020. doi: https://doi.org/10.1016/S0140-6736(20)32544-7.
2. Biohaven’s Rimegepant for Preventative Treatment of Migraine Published in the Lancet. News Release. December 16, 2020. Accessed January 14, 2020. https://www.prnewswire.com/news-releases/biohavens-rimegepant-for-preventive-treatment-of-migraine-published-in-the-lancet-301193664.html.
3. Ashina M. Migraine. The New England Journal of Medicine; November 5, 2020. doi: 10.1056/NEJMra1915327/.