- Lundbeck demonstrates leadership and unwavering commitment to advancing migraine management and supporting patient outcomes with six presentations at the 2025 International Headache Congress (IHC), including three oral presentations on eptinezumab (Vypeti®) and Lu AG09222 (anti-PACAP mAb)
- New data from the open-label extension of the RESOLUTION trial and the primary results of the SUNSET extension trial will be presented for the first time at IHC1,2
- Patients treated with eptinezumab experienced sustained reductions in migraine symptom and burden, including long-term reduction in monthly migraine days (MMDs) and improvements in patient-reported outcomes1,2
H. Lundbeck A/S (Lundbeck) is advancing leadership in migraine with a comprehensive collection of datasets to be presented at the 2025 International Headache Congress, taking place in São Paulo (Sept 10-13).1-6 Among data presented, Lundbeck will announce the full results of the 12-week, open-label extension of the RESOLUTION trial investigating eptinezumab for the prevention of migraine in patients with chronic migraine and associated medication overuse headache (MOH) who also received standardized patient education.1 In addition, new data from the SUNSET open-label extension trial in Japanese patients with chronic migraine will be shared with the scientific community for the first time.2
“Migraine is a chronic, disabling disease that disrupts lives and demands a comprehensive, long-term management approach,” said Johan Luthman, EVP, and Head of Research & Development at Lundbeck. “Patients deserve preventive treatments that not only deliver early relief but sustain their impact over time. The RESOLUTION and SUNSET trials show that patients who experience an early, clinically significant response with eptinezumab continue to maintain this response long-term. This offers renewed hope for those severely impacted by the burden of migraine.”
In the phase 4 RESOLUTION trial,7 the early, clinically meaningful improvements in migraine symptom and burden observed during the initial placebo-controlled period were sustained during the open-label extension period. Around 50% of patients achieved a ≥50% reduction from baseline in monthly migraine days (MMDs) and achieved approximately nine days fewer MMDs at the end of the 12 week OLE, compared to baseline at the start of the RESOLUTION trial (baseline was 20.9 MMDs).1
Additionally, the primary results of the SUNSET trial will be presented at IHC. SUNSET was a 60-week open-label extension of the Asian registrational SUNRISE trial, designed to evaluate the long-term safety, tolerability and efficacy of eptinezumab in a Japanese population with chronic migraine.2
In the trial the symptom reduction observed within the first 12 weeks of treatment with eptinezumab (SUNRISE trial) was maintained across the open-label period.2 The proportion of participants with a ≥50% or ≥75% MMD reduction from baseline was sustained throughout the trial, with 35.7% of patients achieving a 50% reduction in MMD by week 49-60. A trend towards increasing ≥75% response rate was also observed across the 60-weeks extension period.2
Eptinezumab was well tolerated across both trials,1,2 similar to previous trials in migraine prevention and to the current labelled safety information in the United States prescribing information and the EU Summary of Product Characteristics.
These data collectively underscore the long-term effectiveness, tolerability, and safety of eptinezumab in addressing the needs of patients severely impacted by migraine, and underscores Lundbeck’s commitment to lifting the burden of migraine for patients globally.
Details of Lundbeck’s scientific program at IHC:
Satellite symposium
Revolutionizing patient care through science: From neuropeptides to higher standards in migraine prevention. Speakers: Peter J. Goadsby, Gisela Terwindt and Stewart Tepper, Saturday 13 September: 13:00-14:30
Oral presentations
Efficacy and safety of eptinezumab in adults with chronic migraine and medication-overuse headache: 24-week results of the RESOLUTION trial. Presented by Henrik W Schytz. Saturday 13 September: 16:00-17:001
Eptinezumab improved patient-reported disease burden and quality of life in a predominantly Asian population with chronic migraine: Secondary results from the SUNRISE trial. Presented by Patricia Pozo-Rosich. Saturday 13 September: 10:30-11:303
Patient perspectives of migraine symptomology: Insights from exit interviews from the anti-PACAP antibody Phase 2 HOPE trial for migraine prevention. Presented by Richard Lipton. Saturday 13 September: 10:30–11:30.4
ePoster presentations
Eptinezumab reduced disease burden in chronic migraine and medication-overuse headache in patients also receiving patient education: Results from the placebo-controlled RESOLUTION trial. Tepper SJ, et al. Saturday 13th September5
Efficacy and safety of eptinezumab in chronic migraine: Randomized controlled trial in a predominantly Asian population. Yu S, et al. Friday 12th September6
Long-term tolerability and effectiveness of eptinezumab in Japanese adults with chronic migraine: The 60-week, open-label SUNSET trial. Takeshima T, et al. Saturday 13th September2
About migraine and medication-overuse headache (MOH)
Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound.8
Migraine is the second leading cause of years lived with disability (YLD) among all diseases, and it is the top YLD cause among patients aged 15 to 49 years, according to the Global Burden of Disease study.9 As the most prevalent neurological disorder in people aged <50 years, migraine imposes both a social and financial burden. In Europe, migraine alone affects close to 50 million people costing the economy EUR 18 billion annually according to the Cost of Brain Disorders in Europe10 study and this is without the indirect cost associated with presenteeism (i.e. productivity losses due to reduced efficiency of persons who are not sufficiently ill to be absent from work).
Repeated migraine attacks, and often the constant fear of the next one, damage family life, social life, and work life. Furthermore, increased use of acute headache medications may lead to central sensitization and decreased effectiveness of the acute headache medication, resulting in a cycle of increased number of headache days requiring even further increased amounts of acute headache medication. Without proper migraine management, this process results in worsening migraine and may lead to the development of chronic migraine and MOH.11 The secondary headache of MOH is a common complication among individuals with primary headache disorders like chronic migraine.
