AbbVie 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<0.0001). Additionally, the first 12 of the 16 key secondary endpoints met statistical significance, including freedom from MBS at 2 hours after treatment (p<0.0001).1
"Migraine is a highly debilitating disease with a profound impact on daily life. Despite available therapies, many people still encounter barriers to effective, flexible treatment," says Annelies Van Dycke, neurologist, ECLIPSE investigator, and head of neurology at AZ Sint-Jan, Bruges, Belgium. "Providing access to targeted treatments such as atogepant within integrated care plans has the potential to make a meaningful difference in the lives of patients with migraine."
The safety profile of atogepant over the 24-week treatment period was consistent with that observed in previous studies for the preventive treatment of migraine. No new safety signals were observed in the acute treatment of migraine as compared to the safety profile for the preventive treatment of migraine. In the double-blind (DB) period across 24 weeks, the most common treatment-emergent adverse events (≥2%) were nasopharyngitis (4.6%) and upper respiratory tract infection (2.3%).1
About Migraine
Migraine is a prevalent and debilitating neurological disease affecting approximately 14% of the global population, with a higher incidence in women than men.2 Most common among adults aged 25 to 553, migraine attacks are marked by severe, throbbing headaches, sensitivity to light and sound, and nausea, often resulting in significant limitations on daily activities.4 Beyond its physical impact, migraine presents a major socioeconomic challenge worldwide, consistently leading to a higher economic burden than cardiovascular disease or diabetes.*5 In Europe, migraine contributes to GDP losses of 1.2% to 2.0%, with women experiencing four to nine times greater productivity losses in unpaid work compared to men.*5 Despite its substantial effect on work productivity, particularly in unpaid labor, the overall burden of migraine has remained stable over the past decade, highlighting the ongoing need for effective treatment options.*5
About the ECLIPSE Study1
ECLIPSE is a 24-week, Phase 3, multicenter, randomized, double-blind (DB), placebo-controlled, multiple-attack study that enrolled 1,223 adult subjects aged 18 to 75, diagnosed with migraine (with or without aura), who had two to eight migraine attacks of moderate to severe headache pain in each of the three months prior to screening. The study was conducted across 149 sites, including locations in Europe, United Kingdom, Japan, China, South Korea, and Taiwan. The primary endpoint was pain freedom at two hours post dose, while a key secondary endpoint included the absence of the MBS at two hours post dose.
Participants in the ECLIPSE study were randomized to four DB treatment sequences to treat four qualifying migraine attacks with moderate or severe headache with single doses of atogepant (60 mg) or placebo. The first attack (1:1 placebo to atogepant allocation) was the single attack used for the evaluation of the primary and 16 secondary efficacy endpoints. Following the up to 16-week DB period, subjects continued to treat qualifying migraine attacks with atogepant (60 mg) during the open label treatment period until the study concluded at Week 24.
About Atogepant
Atogepant is a once-daily orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine in adults. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks. Atogepant is approved for prophylaxis of migraine in more than 60 countries around the world and marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel, and Puerto Rico.
About AbbVie in Migraine
At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments, and reduce the impact of migraine on their lives.
For more information please visit www.abbvie.com.
