A New Option to Treat and Prevent Migraines for Patients in Europe

The only migraine medication that treats and prevents all in one.

In April 2022, VYDURA® (rimegepant) became the first medicine approved for both acute and prophylactic treatment of migraine in the European Union (EU). Migraine is a leading cause of disability worldwide, with approximately one in ten people living with the condition in Europe alone.1 The burden of illness causes a large economic impact, with the EU spending an estimated ~€50-111 billion in 2011.2 Globally, migraine disproportionately affects women by three to four times compared to men, and over 1 billion patients suffer from migraine.3,4 It is a prevalent and disabling illness, and the personal impact causes missed moments with family, friends, and everyday life.5

“Migraine is often overlooked and undertreated, resulting in substantial disability with suboptimal care for patients,” said Professor Peter Goadsby, Director of the National Institute for Health and Care Research (NIHR) Clinical Research Facility and Professor of Neurology at King’s College London. “VYDURA’s promising efficacy and favorable benefit-risk profile spark hope for people in need of new migraine treatment options.”

VYDURA has been found to be safe and efficacious. A trial in acute migraine demonstrated statistically significant differences versus placebo on pain freedom, freedom from most bothersome symptoms, and ability to function normally at two hours post-dose, and the effects were sustained in some patients through 48 hours.6,7 In a prevention trial, rimegepant taken every other day provided superior reduction in the number of days per month with migraine in weeks 9–12 of the 12-week treatment period compared to placebo.6 The most frequent adverse event in clinical trials with VYDURA was nausea, occurring in 3% of patients compared to 1% with placebo, while hypersensitivity reactions including rash occurred in less than 1% of patients.7

Nurtec OTC patient with dog

Ellie W, actual Nurtec ODT patient

“This approval has the potential to advance the standard of care for migraine in the EU and I believe it will be an important new treatment option for the many people living with the burden of this prevalent neurological disease,” Goadsby said.

  1. Global Burden of Disease (GBD) 2016 Headache Collaborators. Lancet Neurol. 2018;17(11):954-976.
  2. Ashina M. Migraine. N Engl J Med. 2020,383(19): 1866-76.
  3. AHS consensus statement 2021 Ailani J et al. Headache 61:1021–1039.
  4. Global Burden of Disease (GBD) 2016 Headache Collaborators. Lancet Neurol. 2018;17(11):954-976.
  5. CaMEO study data: Buse C headache 2019;59;1286-99, 2018;58:512-14, Mayo Clin Proc 2016;91:596-611. Adapted from Ashina Lancet 2021;397:1485-1496.
  6. VYDURA (rimegepant) [package insert]. Dublin, Ireland: Pfizer Incorporated/Biohaven Pharmaceutical Holding; Company Ltd; 2022.
  7. Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for; the acute treatment of migraine: a randomised, phase 3, double- blind, placebo-controlled trial. Lancet. 2019;394; (10200):737-745