The Food and Drug Administration (FDA) has expanded the approval of Nurtec® ODT (rimegepant) to include preventive treatment of episodic migraine in adults. Previously, the oral calcitonin gene-related peptide receptor (CGRP) antagonist was only indicated for acute treatment of migraine with or without aura.
Nurtec ODT Clinical Trial Data
The approval was based on data from a randomized, double-blind, placebo-controlled phase 2/3 study (ClinicalTrials.gov Identifier: NCT03732638) that assessed the efficacy and safety of rimegepant in adults who had migraines for at least 1 year and 4 to 18 moderate to severe migraine attacks per month over 3 months prior to enrollment. Patients were randomly assigned to receive either rimegepant 75mg orally every other day (n=373) or placebo (n=374). The primary end point was the change from baseline in the mean number of monthly migraine days (MMDs) during weeks 9 through 12 of the double-blind treatment phase.
Findings showed treatment with rimegepant resulted in a statistically significant reduction in MMDs from baseline compared with placebo (-4.3 days vs -3.5 days; P<.010). Additionally, a larger percentage of rimegepant-treated patients achieved at least a 50% reduction from baseline in moderate to severe MMDs during weeks 9 through 12 of the double-blind treatment phase (49.1% vs 41.5%; P=.044). As for safety, the most common adverse reactions reported were nausea and abdominal pain/dyspepsia.
Commenting on the expanded approval, Peter J. Goadsby, MD, PhD, DSc, Professor of Neurology at the University of California, Los Angeles and King’s College London and co-author of the phase 3 preventive study published in The Lancet said, “To have 1 medication patients can use to treat and prevent migraine will likely change the treatment paradigm for many of the millions of people who live with migraine.”
Nurtec ODT is supplied as an orally disintegrating tablet containing 75mg of rimegepant. For preventive treatment of episodic migraine, Nurtec ODT is administered every other day (up to 18 doses/month).
- FDA approves Biohaven’s Nurtec® ODT (rimegepant) for prevention: Now the first and only migraine medication for both acute and preventive treatment. [press release]. New Haven, CT: Biohaven Pharmaceutical; May 27, 2021.
- Nurtec ODT [package insert]. New Haven, CT: Biohaven Pharmaceutical; 2021.