Rimegepant (Nurtec ODT), the first calcitonin gene–related peptide (CGRP) receptor antagonist approved in the United States for the acute treatment of migraine, may help prevent migraine headaches as well.
In a phase 2/3 study, oral rimegepant was superior to placebo in reducing monthly migraine days. About half of adults who took rimegepant experienced a 50% or greater reduction in the number of days of moderate to severe migraines per month.
"This is the first time an oral CGRP migraine treatment has shown dual efficacy in both the acute and preventive treatment of migraine," study coauthor Peter Goadsby, MD, PhD, King's College London, United Kingdom, and the University of California, Los Angeles, said in a news release.
"With this flexibility, these therapies are truly disruptive and change the treatment paradigm for people living with migraine," he added.
The study was published online December 15 in The Lancet.
Beyond Acute Treatment
As reported by Medscape Medical News, the US Food and Drug Administration (FDA) approved oral rimegepant for the acute treatment of migraine in February 2020.
The prevention trial was conducted at 92 centers in the United States. After a 4-week observation period, 747 adults with episodic and chronic migraine were randomly allocated to receive either oral rimegepant 75 mg every other day or matching placebo for 12 weeks.
A total of 695 participants were included in the efficacy analysis ― 348 in the rimegepant group, and 347 in the placebo group.
During weeks 9 to 12, treatment with rimegepant resulted in 4.3 fewer migraine days per month, compared with 3.5 fewer monthly migraine days with placebo, on average (mean difference, -0.8 days; 95% CI, -1.46 to -0.20; P = .0099).
Rimegepant was also superior to placebo on multiple secondary endpoints.
Notably, say the researchers, during weeks 9 to 12, 49% of those taking rimegepant experienced at least a 50% reduction from baseline in the mean number of moderate to severe migraine days per month, compared to 41% in the placebo group.
"The actual reduction in migraine headache days of 4 is certainly within the expected range," coauthor Richard Lipton, MD, Albert Einstein College of Medicine and Montefiore Health System, New York City, told Medscape Medical News.
"The proportion of people with at least a 50% reduction in migraine headache days is a better clinical indicator, and that was excellent," he added.
The incidence of adverse events was similar with rimegepant and placebo, with 36% of patients in each group reporting any adverse event and 1% in each group reporting a serious adverse event.
Adverse events that occurred in at least 2% of rimegepant-treated participants were nasopharyngitis, nausea, urinary tract infection, and upper respiratory tract infection. Nearly all adverse events were mild or moderate in severity.
"Our findings add to evidence that oral CGRP receptor antagonists can provide a targeted novel approach to migraine prevention," the investigators write.
Wrong Endpoint?
In a linked comment, Lars Edvinsson, MD, Lund University, Lund, Sweden, says that although rimegepant was judged to be superior to placebo on the primary endpoint of change in mean number of monthly migraine days, the actual improvement of "less than 1 monthly migraine day is disappointing."
Edvinsson notes that the International Headache Society has proposed that responder rates, such as the percentage of patients achieving ≥50% reduction in migraine or headache days, would be more useful.
"This endpoint is an indicator of clinical usefulness of rimegepant," Edvinsson says.
The FDA has accepted Biohaven's supplemental new drug application for rimegepant for the preventive treatment of migraine. A decision is expected in the second quarter of 2021.
The study was funded by Biohaven Pharmaceuticals. Goadsby and Lipton have financial relationships with the company. A complete list of authors' relevant financial relationships is available with the original article. Edvinsson has received fees paid to his institution for giving talks at conferences sponsored by Amgen, Novartis, Eli Lilly, Teva, and Lundbeck on aspects of migraine pathophysiology.
Lancet. Published online December 15, 2020. Abstract, Comment
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Cite this: CGRP May Offer Both Migraine Treatment and Prevention - Medscape - Dec 22, 2020.
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