FDA Approves Rimegepant for Acute Treatment of Migraine in Adults 

The Food and Drug Administration (FDA) has approved rimegepant (Nurtec; Biohaven, New Haven, CT) for the acute treatment of migraine in adults. Rimegepant is administered as a fast-acting orally disintegrating table and a single dose of 75 mg provides pain relief within 1 hour. Rimegepant also has sustained efficacy with pain relief lasting for as long as 48 hours for many. In clinical trials, 86% of participants treated with a single dose of rimegepant did not need another rescue medication with 24 hours. Rimegepant is expected to be available in pharmacies in March, 2020. 

Rimegepant is a novel quick-dissolve oral tablet formulation that is easy for people with migraine to take discretely and quickly when a migraine attack occurs. The drug is a nonnarcotic antagonist of the calcitonin gene-related peptide (CGRP) receptor, a root cause of migraine. Unlike most acute treatments available for migraine, rimegepant has no cardiac contraindications and few side effects have been seen in clinical trials. More than 3,100 individuals have been treated with rimegepant with more than 113,000 doses administered in clinical trials, including a 1-year long-term safety study. The most common adverse reaction was nausea (2%) in those who received rimegepant vs 0.4% of those who received placebo.

Mary Franklin, executive director of the National Headache Foundation commented, "Everyone knows someone living with migraine, yet it remains an invisible disease that is often overlooked and misunderstood. Almost all people with migraine need an acute treatment to stop a migraine attack as it occurs, which can happen without warning. The approval of Nurtec is exciting for people with migraine as it provides a new treatment option to help people regain control of their attacks and their lives."

Peter Goadsby, MD, PhD, Professor of Neurology and Director of the King's Clinical Research Facility, King's College Hospital commented, "I see many patients in my practice whose lives are disrupted by migraine, afraid to go about everyday life in case of a migraine attack. Many feel unsure if their acute treatment will work and if they can manage the side effects. With the FDA approval of Nurtec, there is renewed hope for people living with migraine that they can get back to living their lives without fear of the next attack."