AbbVie to Present Phase 3 ECLIPSE Data Demonstrating Atogepant (AQUIPTA®) Superiority Over Placebo in Achieving Pain Freedom for the Acute Treatment of Migraine at the 19th European Headache Congress
AbbVieAbbVie(US:ABBV) Prnewswire·2025-12-01 09:00

Core Insights - AbbVie announced positive primary results from the Phase 3 ECLIPSE study, showing atogepant's superiority over placebo in treating acute migraine in adults [1][2] - The study demonstrated significant efficacy in achieving pain freedom and alleviating the most bothersome migraine symptoms within two hours of treatment [2][3] Study Results - Atogepant achieved pain freedom in 24.3% of patients compared to 13.1% for placebo, with an odds ratio of 2.36 and a p-value of less than 0.0001 [2] - The study met its primary endpoint and 12 out of 16 key secondary endpoints, including freedom from the most bothersome symptom at two hours post-treatment [2][5] Safety Profile - The safety profile of atogepant during the 24-week treatment period was consistent with previous studies, with no new safety signals identified [3] - Common treatment-emergent adverse events included nasopharyngitis (4.6%) and upper respiratory tract infection (2.3%) [3] Migraine Impact - Migraine affects approximately 14% of the global population, with a higher incidence in women, particularly those aged 25 to 55 [4] - The socioeconomic burden of migraine is significant, contributing to GDP losses of 1.2% to 2.0% in Europe, with women facing greater productivity losses in unpaid work [4] ECLIPSE Study Details - The ECLIPSE study was a 24-week, multicenter, randomized, double-blind, placebo-controlled trial involving 1,223 adult subjects diagnosed with migraine [5][6] - The study was conducted across 149 sites in various countries, including Europe, Japan, and South Korea [6][7] Atogepant Overview - Atogepant is a once-daily orally administered CGRP receptor antagonist developed for the acute treatment of migraine in adults [9] - It is already approved for migraine prophylaxis in over 60 countries and marketed as AQUIPTA in the EU and QULIPTA in the U.S. [9]