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.