FDA Approves Biohaven's NURTEC® ODT: First and Only Migraine Medication for both Acute and Preventive Treatment

Biohaven Pharmaceutical Holding Company announced that the U.S. FDA has approved NURTEC® ODT (rimegepant 75 mg) for the preventive treatment of migraine. The approved product label was also expanded to include the use of NURTEC ODT 75 mg up to 18 doses/month, allowing for both acute and preventive therapy in the same patient.  

This new approval makes NURTEC ODT the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both acute and preventive treatment. 

NURTEC ODT is approved for acute treatment in all eligible adult patients with migraine, regardless of the number of monthly migraine days. Since approximately 95% of all U.S. migraine patients experience less than 15 headache days per month, the new indication of preventive treatment significantly expands the market potential of NURTEC ODT and provides a new preventive treatment option for the vast majority of people living with migraine.

A recent survey, Preventing Migraine Attacks: A Current Perspective by the National Headache Foundation confirms that 84 percent of people currently taking a preventive treatment wish there was a better treatment option. Among respondents, 53% wanted more migraine free days and 67% reported that their risk of anxiety and depression increases as the number of migraine attacks increase. Nearly all respondents (98%) reported they are willing to consider a new oral treatment.

Peter J. Goadsby, M.D., Ph.D., D.Sc., 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, 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 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."