CGRP-Therapy Atogepant Meets Primary and Secondary End Points in Phase 3 LUNA Trial for Menstrual Migraine

AbbVie recently reported that atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist currently approved for migraine prevention in adults, met the primary end point and all secondary end points among patients with menstrual migraine compared with placebo in the phase 3 LUNA study (NCT06806293). The company noted that it plans regulatory submissions worldwide and presentation of complete findings at future medical meetings.¹

“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, University of Pavia, Italy, said in a statement.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."

LUNA is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial with an open-label extension. It enrolled 468 adult participants with pure menstrual migraine or menstrually related migraine, with or without aura, at sites across Europe and Asia. Diagnoses were based on the International Classification of Headache Disorders, third edition. Participants received atogepant or placebo for 7 consecutive days, beginning 3 days before the anticipated onset of menses, over 3 menstrual cycles. The primary end point was change from baseline in migraine days during the perimenstrual period, averaged across the double-blind treatment period.

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Atogepant reduced perimenstrual migraine days by an average of 1.20 days, compared with 0.40 days for placebo. The between-group difference was 0.80 days in favor of atogepant (P <.0001). The trial also met all 8 ranked secondary end points (all, P <.0001), according to AbbVie. These measures included headache days, moderate or severe headache days, acute medication use, functional disability, cognitive function, and responder outcomes. AbbVie reported that safety findings were consistent with the established profile of atogepant and that no new safety signals emerged.

Menstrual migraine encompasses pure menstrual migraine and menstrually related migraine, both characterized by attacks occurring in temporal association with menstruation. These attacks may be longer, more severe, and less responsive to acute treatment than attacks occurring at other times.² Despite this burden, no therapy is currently approved specifically for menstrual migraine, and management may rely on individualized acute, short-term preventive, or continuous preventive strategies.

Atogepant, marketed as Qulipta, was approved by the FDA in September 2021 for the preventive treatment of episodic migraine, with its indication subsequently expanded to include chronic migraine in April 2023.^3,4 In June 2026, European Commission approved atogepant, marketed as Aquipta, for the acute treatment of migraine in adults with or without aura, expanding the therapy’s label beyond its previously authorized preventive indication. The decision makes atogepant one of the few CGRP receptor antagonists approved in Europe for both the prevention and acute treatment of migraine.⁵

“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," Primal Kaur, MD, senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie, said in a statement.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."

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REFERENCES
1. AbbVie Extends Migraine Leadership with Positive Phase 3 Atogepant Results in Menstrual Migraine. News release. AbbVie. September 10, 2026. Accessed Septemeber 10, 2026. https://news.abbvie.com/2026-09-10-AbbVie-Extends-Migraine-Leadership-with-Positive-Phase-3-Atogepant-Results-in-Menstrual-Migraine
2. Vetvik KG, MacGregor EA. Menstrual migraine: a distinct disorder needing greater recognition. Lancet Neurol. 2021;20(4):304-315. doi:10.1016/S1474-4422(20)30482-8
3. FDA Approves QULIPTA™ (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine. News release. AbbVie. September 28, 2021. Accessed Septemeber 10, 2026. https://news.abbvie.com/news/press-releases/fda-approves-qulipta-atogepant-first-and-only-oral-cgrp-receptor-antagonist-specifically-developed-for-preventive-treatment-migraine.htm?view_id=1531
4. U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine. News release. AbbVie. April 17, 2023. Accessed Septemeber 10, 2026. https://news.abbvie.com/article_display.cfm?article_id=12576
5. AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults. News release. AbbVie. June 2, 2026. Accessed Septemeber 10, 2026. https://news.abbvie.com/news/press-releases/abbvie-announces-european-commission-approval-of-aquipta-atogepant-for-the-acute-treatment-of-migraine-in-adults.htm