AbbVie announces positive Phase 3 LUNA results: Atogepant significantly reduced perimenstrual migraine days, meeting primary and all 8 secondary endpoints.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
AbbVie’s atogepant significantly reduced migraine days during the perimenstrual period compared with placebo in the Phase 3 LUNA study, meeting the primary and all eight ranked secondary endpoints. The results provide Phase 3 evidence for a CGRP-targeted preventive approach in menstrual migraine, a condition with no treatment currently approved specifically for this indication.
Phase 3 LUNA Shows Significant Reduction in Migraine Days
AbbVie reported positive topline results from LUNA, a Phase 3 study evaluating atogepant for the preventive treatment of menstrual migraine in adults. The study met its primary endpoint, with atogepant producing a mean reduction of 1.20 migraine days during the perimenstrual period over three menstrual cycles, compared with 0.40 days with placebo. This translated into 0.80 fewer migraine days versus placebo (p<0.0001).
Atogepant also achieved statistically significant improvements versus placebo across all eight ranked secondary endpoints (p<0.0001). These included headache burden, acute medication use, functional disability, cognitive function and responder outcomes. Safety findings were consistent with the established safety profile of atogepant, with no new safety signals identified.
Menstrual Migraine Remains an Unmet Need
Menstrual migraine includes pure menstrual migraine and menstrually related migraine, with attacks occurring around menstruation during a period of increased biological vulnerability.
These attacks can be more painful, longer lasting and more difficult to treat than migraine occurring outside the menstrual period. Survey data from the European Migraine and Headache Alliance found that 68% of respondents had never been offered a treatment approach tailored specifically to menstrual migraine.
Despite the availability of preventive and acute migraine therapies, no treatment currently carries a specific approval for menstrual migraine, highlighting the need for evidence generated specifically in this population.
Short-Term Preventive Dosing Was Evaluated Across Three Cycles
LUNA enrolled 468 adult women with pure menstrual migraine or menstrually related migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition criteria. The multicenter, randomized, double-blind, placebo-controlled study included sites across Europe and Asia and incorporated an open-label extension.
Participants received atogepant for seven consecutive days beginning three days before the onset of menses, with treatment repeated over three menstrual cycles. The primary endpoint assessed change from baseline in migraine days during the perimenstrual period, averaged across the three-cycle double-blind treatment period.
Secondary endpoints included headache days, moderate or severe headache days, migraine days with moderate or severe headache, acute medication use, responder rates, functional disability and cognitive function.
CGRP Receptor Blockade Provides the Therapeutic Rationale
Atogepant is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist that targets a pathway involved in migraine. AbbVie described LUNA as the first study of a CGRP-targeted treatment to report positive results specifically in menstrual migraine.
Atogepant’s regulatory status varies by market. In the United States, QULIPTA is approved for the preventive treatment of migraine in adults. In the European Union, AQUIPTA is approved for both acute treatment of migraine with or without aura in adults and prophylaxis of migraine in adults with at least four migraine days per month. For prevention, AQUIPTA is taken once daily, while the EU acute indication uses as-needed dosing.
Atogepant is marketed as AQUIPTA in the European Union and QULIPTA in the United States, Canada, Israel and Puerto Rico.
Regulatory Submissions Planned
AbbVie plans to submit the LUNA results to health authorities worldwide and present the findings at future medical congresses. If regulatory submissions support a menstrual migraine indication, the data could expand the use of atogepant into a population defined by a predictable, cycle-associated pattern of migraine for which no therapy currently has a dedicated approval.
Reference
AbbVie Extends Migraine Leadership with Positive Phase 3 Atogepant Results in Menstrual Migraine, AbbVie, 10 September 2026
About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.