Rimegepant Now Approved for Both Acute and Preventive Migraine Treatment

The FDA has approved rimegepant (Nurtec; Biohaven Pharmaceuticals, New Haven, CT) for the additional indication of preventive treatment of migraine. The approval for preventative migraine treatment makes rimegepant the first drug approved to treat acute migraine attacks and help prevent future migraine attacks. 

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 calcitonin gene-related peptide (CGRP) in migraine, and coauthor of the phase 3 preventive study published in The Lancet, commented, "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. 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."

Administered as an orally dissolving tablet, rimegepant rapidly treats a root cause of migraine by blocking the CGRP receptor. Pain relief lasts up to 48 hours after a single 75 mg dose. Taken every other day, rimegepant reduces the number of monthly migraine days. Rimegepant can also be taken up to once daily or as needed to treat attacks when they do occur. This flexible dosing and efficacy for prevention as well as acute treatment potentially provides a more complete, flexible treatment option to give people with migraine increased control of the disease.  

The FDA approval of rimegepant was based on the data from a double-blind randomized placebo-controlled phase 3 clinical trial with an open-label extension. The study demonstrated rimegepant was superior to placebo, decreasing monthly migraine days by 4.3 days/month after 3 months. Approximately half of participants treated with rimegepant had a 50% or more reduction in the number of moderate-to-severe migraine days per month.

Rimegepant was generally well tolerated with the most common adverse events were nausea (2.7% vs .8% in placebo) and stomach pain/indigestion (2.4% vs .8% in placebo).