AbbVie Qulipta (Atogepant) Meets Primary and All Eight Secondary Endpoints of Phase 3 LUNA Trial in Menstrual Migraine; First Potential FDA-Approved Therapy Specifically for Perimenstrual Migraine
AbbVie (NYSE: ABBV) announced Friday September 11, 2026 positive topline results from the Phase 3 LUNA trial evaluating Qulipta (atogepant, an oral calcitonin gene-related peptide receptor antagonist small molecule) for the preventive treatment of menstrual migraine in adults. LUNA is a multicenter randomized double-blind placebo-controlled trial that enrolled 468 adult women with pure menstrual migraine or menstrually-related migraine across sites in Europe and Asia; participants took atogepant for 7 consecutive days starting 3 days before the onset of menses, repeated over 3 menstrual cycles. Atogepant reduced perimenstrual migraine days by a mean of 1.20 days versus 0.40 days with placebo (0.80 fewer migraine days versus placebo, p<0.0001) and met all 8 ranked secondary endpoints (p<0.0001). No treatment is currently FDA-approved specifically for menstrual migraine. AbbVie plans to submit the LUNA data to health authorities and present at future medical congresses. Qulipta is already approved in the U.S. for adults with episodic migraine and chronic migraine — the LUNA readout supports a distinct short-term perimenstrual dosing regimen and potentially a dedicated label expansion. CGRP is a neuropeptide involved in migraine pathophysiology; atogepant is a small-molecule CGRP receptor antagonist rather than a peptide itself.