AbbVie’s Phase 3 ECLIPSE Study Shows Atogepant (AQUIPTA®) Superior to Placebo for Acute Migraine Pain Relief

AbbVie announced primary results from the pivotal Phase 3 ECLIPSE study evaluating atogepant (60 mg) versus placebo for the acute treatment of migraine in adults. The study demonstrated that atogepant was superior to placebo in achieving pain freedom two hours after treatment of the first migraine attack, with 24.3% of patients achieving pain freedom on atogepant compared to 13.1% on placebo. Additionally, atogepant showed superiority in freedom from the most bothersome migraine symptom (MBS) two hours after treatment. These results position atogepant as a promising new acute treatment option for adults living with migraine, with or without aura.​ The study will be presented as a late-breaking presentation at the 19th European Headache Congress.

The ECLIPSE study (NCT06241313) was a 24-week, multicenter, randomized, double-blind, placebo-controlled, multiple-attack trial involving 1,223 adult migraine sufferers from diverse geographic locations including Europe, the UK, Japan, China, South Korea, and Taiwan. Participants treated multiple qualifying migraine attacks with either atogepant or placebo. Pain freedom at two hours post dose was the primary endpoint, while freedom from the most bothersome symptom was a key secondary endpoint. Both primary and key secondary endpoints were met with statistically significant differences favoring Atogepant demonstrate significantly higher proportion of patients achieving pain freedom two hours after treatment compared to placebo 24.3% vs. 13.1%, respectively. Key secondary endpoint of freedom from the most bothersome migraine symptom (such as sensitivity to light, sound, or nausea) at two hours post-dose was also significantly better with atogepant than placebo.

Atogepant is an oral Calcitonin Gene-Related Peptide (CGRP) receptor antagonist. CGRP is a complex protein found on the surface of cells, primarily involved in the pathophysiology of migraine. Atogepant was originally approved for migraine prevention under brand names AQUIPTA® in the EU and QULIPTA® in the US and other countries. The new ECLIPSE data support an expanded indication for atogepant as an acute migraine treatment option. AbbVie has submitted an application to the European Medicines Agency (EMA) seeking approval for this expanded use, which would offer migraine patients increased flexibility in treatment options and improved outcomes in acute attacks.

The safety profile observed during the trial was consistent with previous studies, with no new safety signals identified.​ Treatment-emergent adverse events (TEAEs) were generally mild to moderate, with low rates of discontinuation due to adverse events. Nasopharyngitis occurred in 4.6% of atogepant-treated patients, while upper respiratory tract infection affected 2.3%. 

Migraine is a highly disabling neurological condition affecting about 14% of the global population, mostly adults aged 25 to 55, and significantly impacting quality of life and productivity. Despite existing therapies, many patients face barriers to effective acute treatment, highlighting the unmet need for novel options.

Primal Kaur, M.D., MBA, senior vice president of immunology, neuroscience, eye care and specialty development at AbbVie, stated: “These latest ECLIPSE results mark a step forward in helping more people living with migraine achieve pain freedom and underscore our commitment to addressing unmet needs in acute migraine care. 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.”

In summary, AbbVie’s Phase 3 ECLIPSE study results demonstrate atogepant superiority over placebo in rapidly relieving migraine pain and associated symptoms, reinforcing its potential as a valuable acute treatment option pending regulatory approval in Europe. This advancement marks an important step toward broadening therapeutic choices for the millions affected by migraine worldwide.