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

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Dec 01, 2025, 04:00 ET

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<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.

More information on the ECLIPSE trial can be found at www.clinicaltrials.gov (NCT06241313).

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.

EU Indications and Important Safety Information about AQUIPTA^®▼(atogepant)

Indication

AQUIPTA (atogepant) is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Important Safety Information

Contraindications

AQUIPTA is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

AQUIPTA is not recommended in patients with severe hepatic impairment.

Fertility, pregnancy, and lactation

AQUIPTA is not recommended during pregnancy and in women of childbearing potential not using contraception.

Effects on ability to drive and use machines

AQUIPTA has no or negligible influence on the ability to drive and use machines. However, it may cause somnolence in some patients. Patients should exercise caution before driving or using machinery until they are reasonably certain that AQUIPTA does not adversely affect performance.

Adverse reactions

The most reported adverse drug reactions during AQUIPTA studies were nausea 9%, constipation 8%, and fatigue/somnolence 5%. Most of the reactions were mild or moderate in severity. The adverse drug reaction that most commonly led to discontinuation was nausea 0.4%.

This is not a complete summary of all safety information. See AQUIPTA full summary of product characteristics (SmPC) at www.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

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.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

ALL-ATP-250008

Contact(s):

Global Media:
Amber Landis
+1 (231) 557-6596
[email protected]

U.S. Media:
Jacqueline Karis
+1 (310) 486-4993
[email protected]

Footnotes
*This initiative was funded by AbbVie. All content was designed and delivered by WifOR. AbbVie has had no input into the content, management, preparation, or creation of these materials.

References

¹Annelies Van Dycke, et al. Efficacy, Safety, and Tolerability of Atogepant for the Acute Treatment of Migraine: Results from the ECLIPSE Trial. European Headache Congress 2025.
² Dong L, Dong W, Jin Y, et al. The Global Burden of Migraine: A 30-Year Trend Review and Future Projections by Age, Sex, Country, and Region. Pain and Therapy. 2025;14(1):297-315.
³ What is Migraine. The Migraine Trust. Available at: https://migrainetrust.org/understand-migraine/what-is-migraine. Accessed November 17, 2025.
⁴ Migraine headaches. Cleveland Clinic. Available at: https://my.clevelandclinic.org/health/diseases/5005-migraine-headaches. Accessed October 17, 2025.
⁵ The socioeconomic burden of migraine: The case of 6 European Countries. Wif0r Institute. Available at: https://www.wifor.com/de/download/the-socioeconomic-burden-of-migraine-the-case-of-6-european-countries/?wpdmdl=358248&refresh=685c5ea88c24c1750884008.