AbbVie has announced positive topline results from its Phase 3 LUNA study evaluating atogepant for the preventive treatment of menstrual migraine in adults.
Atogepant, sold as Qulipta in the US and Aquipta in the EU, is a calcitonin gene-related peptide receptor antagonist already approved in 60 countries for general migraine prevention.
The LUNA study is a Phase 3, multicenter, randomised, double-blind, placebo-controlled trial that enrolled 468 adult women across sites in Europe and Asia.
Participants took the drug for seven consecutive days starting three days before the onset of menses, repeated over three menstrual cycles, differing from atogepant’s approved once-daily dosing schedule.
The primary endpoint measured the change from baseline in migraine days during the perimenstrual period, averaged across those three cycles.
Atogepant reduced migraine days during the perimenstrual period by an average of 1.20 days compared to just 0.40 days with placebo, a statistically significant difference of 0.80 fewer days.
The drug met its primary endpoint and all eight ranked secondary endpoints versus placebo, with results achieving a p-value of less than 0.0001 across all measures.
No new safety signals were observed during the trial, indicating the drug maintained its established and favourable safety profile throughout the study period.
Menstrual migraine, which includes pure menstrual migraine and menstrually related migraine, is characterised by attacks that are longer, more severe, and less responsive to acute treatment than attacks at other times of the month.
Despite the significant burden this condition places on women, no therapy is currently approved specifically for the treatment of menstrual migraine anywhere in the world.
“Menstrual migraine attacks are generally more severe and more difficult to treat, making timely intervention particularly important,” said Cristina Tassorelli, MD, PhD, professor of neurology and director of the Headache Science Centre at IRCCS Mondino Foundation, University of Pavia, Italy.
The LUNA study is the first trial of a CGRP-targeted treatment to report positive results specifically in menstrual migraine, marking a significant milestone for a condition long underserved by medicine.
AbbVie said it plans to pursue regulatory submissions worldwide and will present the complete study findings at future medical meetings, moving Qulipta (ABBV) closer to an expanded label.