Data Show Sustained Improvement in Migraine Symptoms With Eptinezumab

New data confirm that the early meaningful improvements in migraine symptoms and burden with eptinezumab (Vyepti) were sustained in an open-label extension period. In the open-label extension of the RESOLUTION (NCT05452239) trial, approximately half of patients achieved a 50% or greater reduction from baseline in monthly migraine days (MMDs) compared with baseline at the start of the RESOLUTION trial.¹

Approximately half of patients achieved a 50% or greater reduction from baseline monthly migraine days and sustained the response. | Image Credit: zinkevych - stock.adobe.com

In addition, patients achieved approximately 9 fewer MMDs at the end of the 12-week open-label extension compared with the baseline at the beginning of the trial at 20.8 MMDs.¹

"Migraine is a chronic, disabling disease that disrupts lives and demands a comprehensive, long-term management approach," Johan Luthman, EVP and head of research & development at Lundbeck, said in a news release.¹ "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."

Migraine can usually last 4 to 72 hours if left untreated, and the frequency varies by patient. During migraine, a patient might have pain on 1 side of their head, throbbing and pulsing pain, sensitivity to light, sound, smell, and touch, and nausea and vomiting.²

Investigators of the original study aimed to determine if eptinezumab could help reduce the number of days with migraine, number of days with headache, and acute medication use for patients with migraine and medication overuse headache (MOH). Individuals included in the study had a diagnosis of migraine or MOH, 8 or more migraine days per month for each month within 3 months prior to screening, 15 or more headache days per month for each month within 3 months prior to screening, and an onset of migraine diagnosis at 50 years or earlier, according to the clinical trial information.³

The primary outcome was change from baseline in number of MMDs at weeks 1 through 4, and secondary end points included change in MMDs at weeks 1 through 12 and weeks 13 through 24, change in monthly headache days at weeks 1 through 4, weeks 1 through 12, and weeks 13 through 24, and change in monthly days with acute medication use.³

Furthermore, primary results from the SUNSET trial, a 60-week open-label extension of the SUNRISE trial, were also announced. The trial was designed to evaluate the long-term safety, tolerability, and efficacy of the drug in a Japanese population with chronic migraine. It showed that the proportion of patients who had a 50% or greater and 75% or greater MMD reduction was sustained, with 35.7% of patients achieving a 50% reduction by week 49 through 60 and an increasing trend for a 75% or greater response rate.¹

Eptinezumab was well tolerated across both trials and showed similar results to migraine preventions and current labeled safety information in the US and EU.¹

READ MORE: Headache and Migraine Resource Center

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REFERENCES

1. Lundbeck showcases new clinical migraine data, including long-term preventive effectiveness of Vyepti (eptinezumab) in patients severely impacted by migraine. News release. H Lundbeck A/S. September 11, 2025. Accessed September 16, 2025. https://www.prnewswire.com/news-releases/lundbeck-showcases-new-clinical-migraine-data-including-long-term-preventive-effectiveness-of-vyepti-eptinezumab-in-patients-severely-impacted-by-migraine-302553630.html

2. Mayo Clinic. Migraine. Updated July 08, 2025. Accessed September 16, 2025. https://www.mayoclinic.org/diseases-conditions/migraine-headache/symptoms-causes/syc-20360201

3. A study of eptinezumab in participants with migraine and medication overuse headache. ClinicalTrials.gov identification: NCT05452239. April 17, 2025. Accessed September 16, 2025. https://clinicaltrials.gov/study/NCT05452239