FDA Approves First Dual Therapy for Acute and Preventive Treatment of Migraine
Rimegepant is indicated for adult patients with episodic migraines.
Officials with the FDA have approved rimegepant 75 mg (Nurtec ODT; Biohaven Pharmaceutical Holding Company Ltd.) for dual therapy of acute migraines and the preventative treatment of migraines in adults. According to Biohaven, the drug product is the first medication approved for both uses.
An oral calcitonin gene-related peptide antagonist, rimegepant is indicated for patients with episodic migraines. The drug was previously approved by the FDA for acute migraines with or without aura in adults.
According to Biohaven, approximately 95% of all patients with migraine in the United States experience less than 15 headache days per month. The new approved product label allows use of rimegepant for up to 18 doses per month, which includes treatment for both acute and preventive therapy in the same patient.
According to Biohaven, migraines can be debilitating, lasting 4 to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, sensitivity to sound, and sensitivity to light.
In a prepared statement, Peter J. Goadsby, MD, PhD, DSc, professor of neurology at the University of California, Los Angeles and King's College London, recipient of the 2021 Brain Prize for his groundbreaking research discovering the role of CGRP in migraine, and co-author of the phase 3 preventive study published in The Lancet, said the new indication for rimegepant is one of the most groundbreaking things to happen in the 40 years that he has been practicing headache medicine.
"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,” said Goadsby.
The new approval for rimegepant is based on a double-blind, randomized, placebo-controlled phase 3 clinical trial with an open label extension. Primary study endpoint results demonstrated that rimegepant decreased monthly migraine days by 4.3 days/month after 3 months of treatment, compared to placebo. The preventive effects of rimegepant were seen as early as the first week of therapy, according to Biohaven. Additionally, a key secondary endpoint result showed that approximately half of patients treated with rimegepant had a 50% or greater reduction in the number of moderate-to-severe migraine days per month.
The most commonly adverse effects reported in the study for patients that used rimegepant were nausea (2.7%) and stomach pain or indigestion (2.4%).
FDA Approves Biohaven's NURTEC® ODT (rimegepant) for Prevention: Now the First and Only Migraine Medication for both Acute and Preventive Treatment [news release]. May 27, 2021; Biohaven Pharmaceutical Holding Company Ltd. [email]