Jul 09, 2025
At EAN 2025, Lundbeck presented new results from the SUNRISE trial (NCT04921384), a pivotal Phase III randomized, placebo-controlled study evaluating eptinezumab for preventive treatment of chronic migraine in a predominantly Asian patient population. The trial addresses a critical unmet need, as migraine-specific treatment use and adherence remain low in Asia despite available options. SUNRISE supports expanding access to VYEPTI, approved by the FDA in 2020 and the European Commission in 2022 for adults with frequent migraines.
EAN 2025 Coverage: Efficacy and Safety of Eptinezumab in Chronic Migraine: Randomized Controlled Trial in a Predominantly Asian Population
SUNRISE enrolled 983 adults (aged 18–75) with chronic migraine mean baseline (MMDs): 17.4 days, randomizing them 1:1:1 to receive a single IV dose of eptinezumab 100 mg, 300 mg, or placebo. The trial population was 63.5% Asian, 36.5% European. All patients entered a 12-week double-blind period, followed by a 12-week dose-blind extension and an 8-week safety follow-up.
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Both eptinezumab doses met the primary efficacy endpoint, demonstrating significantly greater reductions in monthly migraine days compared to placebo.
| Primary Endpoint at Week 12 | |
| Treatment Arm | Mean Change in MMDs (Weeks 1–12) |
| Eptinezumab 300 mg | –7.5 days |
| Eptinezumab 100 mg | –7.2 days |
| Placebo | –4.8 days |
Patients receiving eptinezumab (300 mg or 100 mg) were four times more likely to achieve a ≥75% reduction in monthly migraine days within the first 4 weeks compared to placebo. Eptinezumab also showed rapid preventive efficacy, with more patients migraine-free as early as Day 1, along with greater, clinically meaningful improvements in patient-reported outcomes.
Safety and Tolerability
The safety profile of eptinezumab in the SUNRISE trial remained consistent with previous studies. TEAEs were comparable across all groups, and serious adverse events were infrequent.
| Safety Endpoint | 100 mg | 300 mg | Placebo |
| Any TEAE | 37.6% | 32.2% | 33.5% |
| Serious TEAEs leading to discontinuation | <2% | <2% | <2% |
| Most common TEAE: COVID-19 | 5.5% | 4.6% | 4.3% |
Importantly, no new safety signals emerged, and eptinezumab was well tolerated, supporting its use in diverse populations.
KOL Views
“SUNRISE reinforces eptinezumab’s preventive efficacy and tolerability in chronic migraine, now validated in a predominantly Asian cohort—a population historically underrepresented in migraine trials.” – Expert Opinion.
“Rapid onset from Day 1 and sustained MMD reduction through Week 12 are important for real-world management. These results further support eptinezumab’s role in high-burden chronic migraine patients globally.” – Expert Opinion.
Conclusion
The SUNRISE trial provides compelling new evidence that eptinezumab 100 mg and 300 mg are effective, well-tolerated preventive options for chronic migraine, with demonstrated benefit in a predominantly Asian population. The trial strengthens eptinezumab’s global clinical profile and underscores the need for geographically inclusive research in neurology. With rapid onset, sustained efficacy, and quarterly dosing convenience, eptinezumab continues to set a high standard in migraine prevention.
Article in PDF
Jul 09, 2025
At EAN 2025, Lundbeck presented new results from the SUNRISE trial (NCT04921384), a pivotal Phase III randomized, placebo-controlled study evaluating eptinezumab for preventive treatment of chronic migraine in a predominantly Asian patient population. The trial addresses a critical unmet need, as migraine-specific treatment use and adherence remain low in Asia despite available options. SUNRISE supports expanding access to VYEPTI, approved by the FDA in 2020 and the European Commission in 2022 for adults with frequent migraines.
EAN 2025 Coverage: Efficacy and Safety of Eptinezumab in Chronic Migraine: Randomized Controlled Trial in a Predominantly Asian Population
SUNRISE enrolled 983 adults (aged 18–75) with chronic migraine mean baseline (MMDs): 17.4 days, randomizing them 1:1:1 to receive a single IV dose of eptinezumab 100 mg, 300 mg, or placebo. The trial population was 63.5% Asian, 36.5% European. All patients entered a 12-week double-blind period, followed by a 12-week dose-blind extension and an 8-week safety follow-up.
Both eptinezumab doses met the primary efficacy endpoint, demonstrating significantly greater reductions in monthly migraine days compared to placebo.
| Primary Endpoint at Week 12 | |
| Treatment Arm | Mean Change in MMDs (Weeks 1–12) |
| Eptinezumab 300 mg | –7.5 days |
| Eptinezumab 100 mg | –7.2 days |
| Placebo | –4.8 days |
Patients receiving eptinezumab (300 mg or 100 mg) were four times more likely to achieve a ≥75% reduction in monthly migraine days within the first 4 weeks compared to placebo. Eptinezumab also showed rapid preventive efficacy, with more patients migraine-free as early as Day 1, along with greater, clinically meaningful improvements in patient-reported outcomes.
Safety and Tolerability
The safety profile of eptinezumab in the SUNRISE trial remained consistent with previous studies. TEAEs were comparable across all groups, and serious adverse events were infrequent.
| Safety Endpoint | 100 mg | 300 mg | Placebo |
| Any TEAE | 37.6% | 32.2% | 33.5% |
| Serious TEAEs leading to discontinuation | <2% | <2% | <2% |
| Most common TEAE: COVID-19 | 5.5% | 4.6% | 4.3% |
Importantly, no new safety signals emerged, and eptinezumab was well tolerated, supporting its use in diverse populations.
KOL Views
“SUNRISE reinforces eptinezumab’s preventive efficacy and tolerability in chronic migraine, now validated in a predominantly Asian cohort—a population historically underrepresented in migraine trials.” – Expert Opinion.
“Rapid onset from Day 1 and sustained MMD reduction through Week 12 are important for real-world management. These results further support eptinezumab’s role in high-burden chronic migraine patients globally.” – Expert Opinion.
Conclusion
The SUNRISE trial provides compelling new evidence that eptinezumab 100 mg and 300 mg are effective, well-tolerated preventive options for chronic migraine, with demonstrated benefit in a predominantly Asian population. The trial strengthens eptinezumab’s global clinical profile and underscores the need for geographically inclusive research in neurology. With rapid onset, sustained efficacy, and quarterly dosing convenience, eptinezumab continues to set a high standard in migraine prevention.
