AbbVie Extends Migraine Leadership with Positive Phase 3 Atogepant Results in Menstrual Migraine

• Menstrual migraine is a recurrent, debilitating migraine pattern, with attacks occurring around or during the menstrual period, a predictable time of increased biological vulnerability^2,4
• Atogepant demonstrated statistically significant reductions in migraine days associated with the menstrual period, meeting the primary and all eight ranked secondary endpoints versus placebo in the Phase 3 LUNA study (p<0.0001)¹
• No treatment options are currently approved for menstrual migraine, underscoring the urgent need for care approaches specifically designed for this patient population^2,5

NORTH CHICAGO, Ill., Sept. 10, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3 LUNA study, which evaluated atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of menstrual migraine in adults.¹ These results reinforce AbbVie's scientific expertise in migraine and its focus on advancing solutions for people living with complex and disabling migraine attacks.

"These positive Phase 3 LUNA results represent an important advancement for people living with menstrual migraine, with atogepant demonstrating superior efficacy versus placebo across the primary endpoint and all eight ranked secondary endpoints," said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. "Menstrual migraine attacks can be severe, long lasting and disruptive to daily life. These data bring us closer to our goal of bringing a potential treatment option for women living with this debilitating disease."

Atogepant Met Primary and All Ranked Secondary Endpoints in Phase 3 LUNA

The study evaluated atogepant taken for seven consecutive days starting three days before the onset of menses over three menstrual cycles.¹ Atogepant met the primary endpoint, demonstrating a greater reduction than placebo in migraine days during the perimenstrual period, averaged across three menstrual cycles during the double-blind period. The average reduction was 1.20 days with atogepant versus 0.40 days with placebo, corresponding to 0.80 fewer migraine days versus placebo (p<0.0001).¹ Atogepant also demonstrated statistically significant and clinically meaningful improvements versus placebo across all eight ranked secondary endpoints (p<0.0001), including measures of headache burden, acute medication use, functional disability, cognitive function and responder outcomes.¹ Safety results were consistent with the known safety profile of atogepant, with no new safety signals observed.^1,7

Menstrual Migraine Can Carry a Significant Burden

Survey data from the European Migraine and Headache Alliance Migraine in Women Survey provide additional context on the burden of headache attacks occurring around menstruation. Respondents described these attacks as more painful, longer lasting or more resistant to medication than non-menstrual attacks, and 68% reported they had never been offered a tailored treatment approach.³

"Menstrual migraine attacks are generally more severe and more difficult to treat, making timely intervention particularly important," said Cristina Tassorelli, M.D., Ph.D., professor of neurology and director of the Headache Science Centre at IRCCS Mondino Foundation, University of Pavia, Italy. "LUNA is the first study of a CGRP-targeted treatment to report positive results specifically in menstrual migraine and meets an important unmet need for women."

AbbVie plans to submit these data to health authorities worldwide and present findings at future medical congresses.

About Menstrual Migraine

Menstrual migraine includes pure menstrual migraine and menstrually-related migraine, with attacks occurring around menstruation during a period of increased biological vulnerability.^2,4 In the Chronic Migraine Epidemiology and Outcomes–International (CaMEO-I) study, 66% (n=4,220/6,395) of eligible respondents reported migraine attacks around menstruation.⁸

About the LUNA (M24-859) Study

LUNA is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension evaluating the efficacy, safety and tolerability of atogepant for the preventive treatment of menstrual migraine.^1,6 The study enrolled 468 adult female participants with pure menstrual migraine or menstrually-related migraine, with or without aura, as defined by the International Classification of Headache Disorders, 3rd edition (ICHD-3), at study locations across Europe and Asia.^4,6 The primary endpoint assessed change from baseline in migraine days during the perimenstrual period, averaged across three menstrual cycles during the double-blind period. Secondary endpoints assessed headache days, moderate or severe headache days, acute medication use days, migraine days with moderate or severe headache, responder outcomes, functional disability and cognitive function.^1,6

More information on the LUNA trial can be found at www.clinicaltrials.gov (NCT06806293).⁶

About Atogepant

Atogepant is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, a class of treatments that targets a pathway involved in migraine.⁷ For preventive treatment, atogepant is taken once daily; for acute treatment, it is taken as needed.⁷ Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries.

U.S. Uses and Important Safety Information

What is QULIPTA® (atogepant)?

QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA.

Before taking QULIPTA, tell your healthcare provider about all your medical conditions, including if you:

• Have high blood pressure
• Have circulation problems in your fingers and toes
• Have kidney problems or are on dialysis
• Have liver problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines.

QULIPTA can cause serious side effects, including:

• Allergic (hypersensitivity) reactions, including anaphylaxis: Serious allergic reactions can happen when you take QULIPTA or days after. Stop taking QULIPTA and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: swelling of the face, lips, or tongue; itching; trouble breathing; hives; or rash.
• High blood pressure: New or worsening of high blood pressure can happen. Contact your healthcare provider if you have an increase in blood pressure.
• Raynaud's phenomenon: A type of circulation problem can worsen or happen. Raynaud's phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.

The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA.

QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit

www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit

AbbVie.com/PatientAccessSupport to learn more.

Please see full Prescribing Information.

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 and solutions 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 including immunology, neuroscience and oncology – 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 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 2025 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.

References

1. Data on file. AbbVie Inc. Study M24-859 (LUNA), Phase 3 primary analysis of the double-blind treatment period. 21 August 2026. ABVRRTI8388.
2. Vetvik, K. G., & MacGregor, E. A. (2021). Menstrual migraine: A distinct disorder needing greater recognition. The Lancet Neurology, 20(4), 304–315. https://doi.org/10.1016/S1474-4422(20)30482-8
3. European Migraine & Headache Alliance. (n.d.). The invisible hormonal pattern in women: Migraine in women survey. Retrieved August 26, 2026, from https://www.emhalliance.org/project/the-invisible-hormonal-pattern-in-women/
4. Headache Classification Committee of the International Headache Society. (2018). The International Classification of Headache Disorders, 3rd edition. Cephalalgia, 38(1), 1–211. https://doi.org/10.1177/0333102417738202
5. Puledda, F., Sacco, S., Diener, H. C., et al. (2024). International Headache Society global practice recommendations for preventive pharmacological treatment of migraine. Cephalalgia, 44(9), 3331024241269735. https://doi.org/10.1177/03331024241269735
6. ClinicalTrials.gov. (n.d.). Study of oral atogepant to assess adverse events and change in disease activity in adult participants with menstrual migraine (ATO MM) (NCT06806293). Retrieved August 26, 2026, from https://clinicaltrials.gov/study/NCT06806293
7. European Medicines Agency. (n.d.). AQUIPTA (atogepant): EPAR product information. Retrieved August 26, 2026, from https://www.ema.europa.eu/en/medicines/human/EPAR/aquipta
8. Ailani, J., Pavlovic, J. M., Kuruvilla, D., Naccara, N., Fanning, K. M., Contreras-De Lama, J., & Buse, D. C. (2026, April 18–22). Characterizing a population reporting menstrually related migraine: Multi-country results from the Chronic Migraine Epidemiology and Outcomes–International (CaMEO-I) study [Conference presentation abstract]. 78th Annual Meeting of the American Academy of Neurology, Chicago, IL, United States. https://doi.org/10.1212/WNL.0000000000215508. https://www.aan.com/msa/Public/Events/AbstractDetails/64507

SOURCE AbbVie