AbbVie's Atogepant Hits Primary and All Eight Secondary Endpoints in Phase III Menstrual Migraine Trial
核心洞察
AbbVie's oral CGRP receptor (搜索) antagonist atogepant met the primary endpoint in the Phase III LUNA study of menstrual migraine (搜索), cutting perimenstrual migraine (搜索) days by 1.20 versus 0.40 with placebo.
All eight ranked secondary endpoints, spanning headache burden, acute medication use, functional disability, cognitive function and responder outcomes, improved significantly versus placebo (p<0.0001).
No targeted therapy is currently approved for menstrual migraine (搜索), and 68% of surveyed women said they had never been offered a tailored treatment approach.
AbbVie reported positive topline results from the Phase III LUNA study of atogepant, its orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of menstrual migraine (搜索) in adults. The trial met its primary endpoint and all eight ranked secondary endpoints versus placebo, marking the first time a CGRP-targeted treatment has reported positive results specifically in this indication, according to the company.
The data, announced September 10, 2026, position atogepant — marketed as QULIPTA in the U.S., Canada, Israel and Puerto Rico and as AQUIPTA in the EU — for a potential label expansion into a patient population for which no therapy is currently approved.
Primary endpoint results
In LUNA, atogepant was taken for seven consecutive days starting three days before the onset of menses, over three menstrual cycles. The primary endpoint assessed change from baseline in migraine (搜索) 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 (搜索) days versus placebo (p<0.0001). Atogepant also demonstrated statistically significant and clinically meaningful improvements versus placebo across all eight ranked secondary endpoints (p<0.0001), which included measures of headache burden, acute medication use, functional disability, cognitive function and responder outcomes.
Safety results were consistent with the known safety profile of atogepant, with no new safety signals observed. The most common side effects of QULIPTA listed in its U.S. prescribing information are nausea, constipation, and fatigue/sleepiness.
"These positive Phase 3 LUNA results represent an important advancement for people living with menstrual migraine (搜索), 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."
Trial design and population
LUNA (M24-859) is a Phase III, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension evaluating the efficacy, safety and tolerability of atogepant for menstrual migraine (搜索) prevention. It enrolled 468 adult female participants with pure menstrual migraine or menstrually-related migraine (搜索), with or without aura, as defined by the International Classification of Headache Disorders, 3rd edition (ICHD-3), at study locations across Europe and Asia.
Secondary endpoints assessed headache days, moderate or severe headache days, acute medication use days, migraine (搜索) days with moderate or severe headache, responder outcomes, functional disability and cognitive function. The trial is registered as NCT06806293.
"Menstrual migraine (搜索) 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."
An unmet need with no approved targeted options
Menstrual migraine (搜索) includes pure menstrual migraine and menstrually-related migraine (搜索), with attacks occurring around menstruation during a period of increased biological vulnerability. 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.
Survey data from the European Migraine (搜索) and Headache Alliance Migraine in Women Survey provide additional context on disease burden. Respondents described attacks occurring around menstruation 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.
No treatment options are currently approved for menstrual migraine (搜索). Physicians have typically prescribed preventive or acute options developed for other forms of migraine (搜索) in this context. By some estimates cited in the source materials, menstrual migraine affects around 12 million women in the U.S. alone, and studies show that up to two-thirds of women who experience regular migraines report attacks tied to their menstrual cycle.
Regulatory path and commercial outlook
AbbVie said it plans to submit the LUNA data to health authorities worldwide and to present the findings at future medical congresses. Atogepant is already approved in 60 countries; for preventive treatment it is taken once daily, and for acute treatment as needed.
The company's migraine (搜索) portfolio also includes Botox (onabotulinumtoxin-A (搜索)) and the acute therapy Ubrelvy (ubrogepant). Qulipta has already become a blockbuster, generating more than $2.3 billion in sales last year, and GlobalData (搜索), parent company of Clinical Trials Arena, forecasts peak sales of just over $2 billion in 2031. Moving into menstrual migraine (搜索) prophylaxis could open an additional market free from competition from other CGRP drugs.
QULIPTA is contraindicated in patients who have had an allergic reaction to atogepant or any of its ingredients. Its label carries warnings for serious hypersensitivity reactions including anaphylaxis, new or worsening high blood pressure, and Raynaud's phenomenon. Patients with high blood pressure, circulation problems in the fingers and toes, kidney problems or on dialysis, or liver problems should inform their healthcare provider before taking the drug, as should those who are pregnant, planning to become pregnant, or breastfeeding.