Pivotal Phase 3 ECLIPSE study demonstrated atogepant is superior to placebo for achieving pain freedom at two hours after treatment of the first migraine attack (24.3% for atogepant vs. 13.1% for placebo)1
AbbVie has submitted an application to the European Medicines Agency for expanded use of atogepant for the acute treatment of adults with migraine across Europe
NORTH CHICAGO, Ill., Dec. 1, 2025 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced primary results from the pivotal Phase 3 ECLIPSE study, evaluating the safety, efficacy and tolerability of atogepant (60 mg) versus placebo for the acute treatment of migraine in adults (with or without aura). The study met its primary and key secondary endpoints, with atogepant demonstrating superiority in pain freedom and freedom from most bothersome migraine symptom (MBS) two hours after treatment of the first migraine attack.1 The results from the randomized, double-blind, placebo-controlled, multiple-attack ECLIPSE study have been accepted as a late-breaking presentation at the European Headache Congress, to be held December 3-6 in Lisbon, Portugal.
“These latest ECLIPSE results mark a step forward in helping more people living with migraine achieve pain freedom and underscores our commitment to addressing unmet needs in acute migraine care,” said Primal Kaur, M.D., MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie. “With our submission to the European Medicines Agency, AbbVie remains dedicated to broadening treatment choices for patients. If approved, atogepant would offer a new acute treatment option for migraine attacks in Europe.”
The Phase 3 ECLIPSE study demonstrated that atogepant was superior to placebo in achieving pain freedom at two hours after treatment of the first migraine attack in adults with a history of migraine (with or without aura) (24.3% for atogepant vs. 13.1% for placebo; odds ratio 2.36, 95% CI [1.76, 3.15]; p