FDA expands rimegepant indication to include migraine prevention


The U.S. Food and Drug Administration has expanded the indication for rimegepant (Nurtec ODT, Biohaven) to include prevention of migraine in adults. Last year, rimegepant became the first calcitonin gene-related peptide (CGRP) receptor antagonist, available in a fast-acting orally disintegrating tablet, to be approved for the acute treatment of migraine with or without aura in adults.

Rimegepant is currently the only migraine medication approved to both treat acute migraine attacks and help prevent future migraine attacks.

The new indication allows for use of rimegepant for preventive treatment in adults with episodic migraine (more than 15 migraine days per month). Rimegepant may be used for up to 18 doses per month, which includes both acute and preventive therapy.

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.

The most common adverse effects of rimegepant therapy were nausea (2.7%) and stomach pain or indigestion (2.4%).

The FDA approval of rimegepant for the preventive treatment of migraine, along with its acute treatment indication, is “one of the most ground-breaking things to happen to migraine treatment in my 40 years of practicing headache medicine,” Peter J. Goadsby, MD, PhD, an investigator in the prevention study, said in a company news release.

“To have one 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,” said Dr. Goadsby, professor of neurology, University of California, Los Angeles and King’s College, London.

A version of this article first appeared on

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