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.

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.”


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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).

References

  1. 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.
  2. Nurtec ODT [package insert]. New Haven, CT: Biohaven Pharmaceutical; 2021.