NURTEC® ODT (rimegepant) receives additional approval for preventive treatment for adult patients with episodic migraine

On May 27, 2021, the US Food and Drug Administration (FDA) has approved the expanded label of NURTEC ODT 75 mg for the preventive treatment of migraine. Rimegepant was the first oral treatment option of its class to treat acute migraine attacks, and now, this CGRP small molecule antagonist is now indicated to prevent migraine attacks as well. In addition, the newly approved product label allows the use of rimegepant up to 18 doses per month for both acute and preventive therapy, regardless of the number of monthly migraine days.

This approval represents a significant milestone for the therapy, making it an eligible treatment option for the majority of individuals with migraine. Peter J Goadsby, MD, PhD, DSc, commented in the press release, “The FDA approval of NURTEC ODT for the preventive treatment of migraine—along with its acute treatment indication—is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine.”

Clinical Trial1

According to the press release, the FDA approval of the expanded product label was based on a double-blind, randomized, placebo-controlled Phase 3 clinical trial with an open-label extension. The primary end point demonstrated that rimegepant was superior to placebo, decreasing monthly migraine days by 4.3 days/month after 3 months of treatment in adult patients with episodic migraine. In the preventive trial, rimegepant was generally well tolerated with the most common side effects being nausea (2.7% vs 0.8% in placebo) and stomach pain/indigestion (2.4% vs. 0.8% in placebo).

This article is notice of a new approval, not intended to be an endorsement of a particular product and/or treatment modality.

Reference: 1. Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51-60. doi: 10.1016/S0140-6736(20)32544-7. Epub 2020 Dec 15. PMID: 33338437.

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