AbbVie has reported positive topline results from its Phase 3 LUNA study, with atogepant showing superior efficacy to placebo in preventing menstrual migraine in adults.
The results mark a significant development in the company’s efforts to expand treatment options for people living with severe and disabling migraine attacks.
The LUNA study evaluated atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, when taken for seven consecutive days beginning three days before the onset of menstruation. The study followed participants across three menstrual cycles.
Atogepant met the study’s primary endpoint, producing a greater reduction in migraine days during the perimenstrual period than placebo. Patients receiving atogepant experienced an average reduction of 1.20 migraine days, compared with 0.40 days for placebo — a difference of 0.80 days in favor of atogepant.
The drug also achieved statistically significant and clinically meaningful improvements across all eight ranked secondary endpoints, including headache burden, acute medication use, functional disability, cognitive function and responder outcomes.
"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, 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."
Menstrual migraine can be particularly challenging for patients, with attacks often reported as more painful, longer lasting and harder to treat than migraines occurring at other times.
Survey data from the European Migraine and Headache Alliance’s Migraine in Women Survey found that 68% of respondents had never been offered a tailored treatment approach for menstrual migraine.
"Menstrual migraine attacks are generally more severe and more difficult to treat, making timely intervention particularly important," said Cristina Tassorelli, 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 said the safety findings were consistent with the known safety profile of atogepant, with no new safety signals identified.
