Atogepant Meets End Points in Menstrual Migraine Trial

AbbVie announced positive topline results from the phase 3 LUNA (NCT06806293) study evaluating atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of menstrual migraine in adults. The company said the data reinforce its position in migraine care and its focus on treatments for complex, disabling attack patterns.¹

Atogepant met the primary end point, showing a greater reduction than placebo in migraine days during the perimenstrual period, averaged across 3 menstrual cycles during the double-blind treatment period. Participants taking atogepant had an average reduction of 1.20 migraine days, compared with 0.40 days for placebo, a difference of 0.80 fewer migraine days (P < .0001).¹

The drug also showed statistically significant and clinically meaningful improvements over placebo on all 8 ranked secondary end points (P < .0001), including headache burden, acute medication use, functional disability, cognitive function, and responder outcomes. Safety results were consistent with atogepant's known profile, and no new safety signals emerged.¹

Dosing Differs From Approved Migraine Prevention Schedule

In LUNA, participants took atogepant for 7 consecutive days, beginning 3 days before the anticipated onset of menses, over 3 menstrual cycles. That intermittent, cycle-timed schedule differs from the once daily continuous dosing currently approved for atogepant's existing preventive migraine indication.

"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 end point and all 8 ranked secondary endpoints," Primal Kaur, MD, senior vice president, global development of immunology, neuroscience, eye care, and specialty at AbbVie, said in a news release.¹ "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."

AbbVie plans to submit the LUNA data to health authorities worldwide and present findings at future medical congresses.¹

Trial Enrolled Nearly 470 Women Across Europe and Asia

LUNA (M24-859) is a phase 3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension.^1,2 The trial 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, at study sites across Europe and Asia.

To qualify, participants needed regular menstrual cycles of 21 to 35 days, a migraine history of at least 12 months, migraine onset before age 50 years, and diary-confirmed migraine attacks starting during the perimenstrual period—defined as day -2 to day +3 relative to menses onset—in at least 2 of 3 cycles. Participants with 15 or more headache days per month, a chronic migraine diagnosis, or migraine with brainstem aura, hemiplegic migraine, or retinal migraine were excluded.²

During the double-blind period, participants received either oral atogepant or a matching placebo for 3 menstrual cycles. All participants received atogepant during the subsequent open-label period.²

Menstrual migraine, which includes both pure menstrual migraine and menstrually related migraine, occurs during a period of increased biological vulnerability tied to menstruation. Data the company cited from the Chronic Migraine Epidemiology and Outcomes–International study found that 66% of eligible respondents reported migraine attacks around menstruation.¹

Survey Data Point to Gaps in Diagnosis and Care

European Migraine & Headache Alliance’s (EMHA) Migraine in Women Survey illustrates the burden of menstrual migraine in patients with migraine. In that survey of 5410 screened-positive respondents, two-thirds said their headache attacks were linked to their menstrual cycle, and of those who compared their period-related attacks with nonmenstrual ones, roughly 90% reported the menstrual attacks were more painful or longer lasting. Approximately 80% of those who commented on medication response said their period-related headaches were more resistant to treatment.³

Despite that reported pattern, 68% of all EMHA survey respondents said their physicians never mentioned treatment options tailored to menstrual or menopausal headache attacks, and only 23% said they had been offered specific treatment options. Respondents who did receive tailored treatment were more likely to rate it as very effective than those who did not.³

"Menstrual migraine attacks are generally more severe and more difficult to treat, making timely intervention particularly important," Cristina Tassorelli, MD, PhD, professor of neurology and director of the Headache Science Centre at IRCCS Mondino Foundation at the University of Pavia, Italy, said in the release.¹ "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."

What It Means for Pharmacists

No treatment is currently approved specifically for menstrual migraine, leaving patients and prescribers to rely on general migraine preventives or short-term strategies timed around the menstrual cycle. Atogepant itself is already marketed for migraine prevention generally—as Qulipta in the United States, Canada, Israel, and Puerto Rico, and as Aquipta in the European Union—and is approved in 60 countries, taken once daily for prevention or as needed for acute treatment.¹

Pharmacists are often positioned to catch the cyclical pattern of menstrual migraine, given the EMHA data showing many patients have never had that connection raised by a physician. Counseling points relevant to atogepant, per its existing labeling, include monitoring for hypersensitivity reactions, new or worsening high blood pressure, and Raynaud's phenomenon, along with the most common side effects of nausea, constipation, and fatigue or sleepiness.^1,3

AbbVie has not yet indicated a timeline for a regulatory submission specific to menstrual migraine; the company said only that it intends to submit the LUNA data to health authorities worldwide.¹

REFERENCES

1. AbbVie extends migraine leadership with positive phase 3 atogepant results in menstrual migraine. News release. AbbVie. September 10, 2026. Accessed September 11, 2026. https://news.abbvie.com/2026-09-10-AbbVie-Extends-Migraine-Leadership-with-Positive-Phase-3-Atogepant-Results-in-Menstrual-Migraine

2. Study of oral atogepant to assess adverse events and change in disease activity in adult participants with menstrual migraine (M24-859). AbbVie Clinical Trials. Accessed September 11, 2026. https://www.abbvieclinicaltrials.com/study/M24-859

4. European Migraine & Headache Alliance. EMHA Migraine in Women Survey: Final Analysis. https://www.emhalliance.org/wp-content/uploads/EMHA-Migraine-Women-Surveys-Final-Analyses.pdf