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AbbVie Unveils ECLIPSE Phase 3 Data on Atogepant at European Headache Congress

AbbVie, a global biopharmaceutical leader, recently made headlines by presenting the pivotal Phase 3 ECLIPSE study results at the 19th European Headache Congress, held in Lisbon, Portugal, from December 3 to 6, 2025. This study assessed the safety, efficacy, and tolerability of Atogepant, an oral medication dosed at 60 mg, in comparison to a placebo for the acute treatment of migraine in adults.

Significant Findings from the ECLIPSE Trial

The ECLIPSE trial highlighted Atogepant's significant superiority over the placebo, demonstrating that 24.3% of patients treated with Atogepant achieved complete pain relief two hours after handling their first migraine attack, in stark contrast to just 13.1% in the placebo group. This data showcases an odds ratio of 2.36, with a staggering p-value of less than 0.0001, signifying the strength of these findings. Moreover, among the 16 key secondary endpoints assessed, many exhibited statistical significance, particularly the resolution of migraine-associated symptoms two hours post-treatment.

Primal Kaur, M.D., MBA, AbbVie's Senior Vice President of Immunology, Neuroscience, and Specialized Development, emphasized the importance of these results in addressing the unmet needs within acute migraine management. AbbVie has also filed a submission with the European Medicines Agency (EMA) to expand Atogepant's use for treating acute migraine in adults across Europe.

Addressing the Burden of Migraine

Migraine is a prevalent neurological condition that severely impacts daily life for roughly 14% of the global population, disproportionately affecting women. Symptoms include intense, throbbing headaches, accompanied by light and sound sensitivity, as well as nausea. The ongoing social and economic challenges posed by migraines are particularly striking, resulting in economic losses equivalent to 1.2% to 2.0% of GDP in Europe. Women, especially, face up to nine times greater losses in unpaid productivity compared to men.

Annelies Van Dycke, a neurologist and lead investigator in the ECLIPSE trial, stated, "Migraine is a debilitating condition with a profound impact on daily life. Despite available treatments, many individuals still find significant barriers to accessing effective options. Atogepant is poised to provide a flexible and accessible treatment solution within integrated healthcare plans, which could vastly improve the quality of life for migraine sufferers."

Study Details and Conclusion

The ECLIPSE study was a randomized, double-blind, placebo-controlled trial deploying 1,223 adults aged 18 to 75 who were diagnosed with migraine, whether with or without aura. Participants had experienced cluster headaches classified as moderate to severe in the past three months and were evaluated at 149 different centers across regions including Europe, the UK, Japan, and Taiwan.

Overall, ECLIPSE aims to illuminate a pivotal option for individuals battling acute migraines. AbbVie's commitment to expanding treatment avenues manifests through their continuous efforts in scientific research and medication accessibility.

By shedding light on Atogepant's promising efficacy, the ECLIPSE trial serves as a beacon of hope for the many individuals enduring the burdensome effects of migraines, addressing both their healthcare needs and quality of life.