AbbVie's Atogepant Shows Superior Efficacy in Phase 3 ECLIPSE Trial for Acute Migraine Treatment
Key Insights
AbbVie (search)'s Phase 3 ECLIPSE study demonstrated atogepant's superiority over placebo for acute migraine (search) treatment, achieving pain freedom in 24.3% of patients versus 13.1% with placebo at two hours post-dose.
The randomized, double-blind trial enrolled 1,223 adults across 149 global sites and met its primary endpoint with statistical significance (p<0.0001) and an odds ratio of 2.36.
AbbVie (search) has submitted a regulatory application to the European Medicines Agency (search) seeking expanded approval for atogepant as an acute migraine (search) treatment option in Europe.
AbbVie (search) announced positive results from its pivotal Phase 3 ECLIPSE study, demonstrating that atogepant (60 mg) significantly outperformed placebo in providing pain freedom for acute migraine (search) treatment. The study achieved its primary endpoint, with 24.3% of patients experiencing pain freedom at two hours after treatment compared to 13.1% with placebo (odds ratio 2.36, 95% CI [1.76, 3.15]; p<0.0001).
The company has submitted an application to the European Medicines Agency (search) for expanded use of atogepant for acute treatment of adults with migraine (search) across Europe, potentially offering a new therapeutic option in the region.
Study Design and Patient Population
The ECLIPSE trial was a 24-week, multicenter, randomized, double-blind, placebo-controlled, multiple-attack study that enrolled 1,223 adult subjects aged 18 to 75. Participants were diagnosed with migraine (search) (with or without aura) and experienced 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 in multiple regions, including 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 most bothersome migraine (search) symptom (MBS) at two hours post-dose.
Participants were randomized to four double-blind treatment sequences to treat four qualifying migraine (search) attacks with moderate or severe headache using single doses of atogepant (60 mg) or placebo. The first attack used a 1:1 placebo to atogepant allocation and served as the basis for evaluating the primary and 16 secondary efficacy endpoints.
Efficacy Results
Beyond the primary endpoint, atogepant demonstrated statistical significance in the first 12 of 16 key secondary endpoints, including freedom from MBS at 2 hours after treatment (p<0.0001). These results represent a meaningful advance in acute migraine (search) care, according to study investigators.
"Migraine (search) is a highly debilitating disease with a profound impact on daily life. Despite available therapies, many people still encounter barriers to effective, flexible treatment," said 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."
Safety Profile
The safety profile of atogepant over the 24-week treatment period remained consistent with previous studies conducted for the preventive treatment of migraine (search). No new safety signals were observed in the acute treatment setting compared to the established safety profile for preventive treatment.
During the double-blind period across 24 weeks, the most common treatment-emergent adverse events (≥2%) were nasopharyngitis (4.6%) and upper respiratory tract infection (2.3%). The overall safety data supports the drug's tolerability profile in this new indication.
Mechanism of Action and Current Approvals
Atogepant is a once-daily orally administered CGRP receptor (search) antagonist specifically developed for migraine (search) treatment. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks.
The drug is currently approved for prophylaxis of migraine (search) in more than 60 countries worldwide and is marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel, and Puerto Rico. The current EU indication covers prophylaxis of migraine in adults who have at least 4 migraine days per month.
Clinical Context
Migraine (search) affects approximately 14% of the global population, with a higher incidence in women than men. The condition is most common among adults aged 25 to 55, with attacks characterized by severe, throbbing headaches, sensitivity to light and sound, and nausea, often resulting in significant limitations on daily activities.
Beyond its physical impact, migraine (search) presents a major socioeconomic challenge worldwide, consistently leading to a higher economic burden than cardiovascular disease or diabetes. 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.
"These latest ECLIPSE results mark a step forward in helping more people living with migraine (search) 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 (search). "With our submission to the European Medicines Agency (search), 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 ECLIPSE study results have been accepted as a late-breaking presentation at the European Headache Congress, scheduled for December 3-6 in Lisbon, Portugal.