Atogepant (Qulipta/Aquipta) met the primary endpoint and all eight ranked secondary endpoints in the Phase III LUNA trial evaluating preventive treatment of menstrual migraine, AbbVie (NYSE: ABBV) reported. No treatment is currently approved specifically for menstrual migraine, meaning the data could support a dedicated menstrual-migraine indication.
The LUNA study is a Phase III, 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. The dosing regimen differed from atogepant's approved once-daily preventive use: participants took the drug for seven consecutive days starting three days before the onset of menses, repeated over three menstrual cycles. The primary endpoint was the change from baseline in migraine days during the perimenstrual period, averaged across those three cycles.
Atogepant produced a mean reduction of 1.20 migraine days versus 0.40 days with placebo — a difference of 0.80 days (p<0.0001). All eight ranked secondary endpoints, covering headache burden, acute medication use, functional disability, cognitive function, and responder rates, also reached statistical significance (p<0.0001). Safety was consistent with atogepant's established profile, with no new signals identified.
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that blocks CGRP from binding to its receptor, interrupting a signaling pathway elevated during migraine attacks. The drug is already approved in the US for both episodic and chronic migraine prevention under the brand name Qulipta, and in June 2026 received European Commission approval for the acute treatment of migraine in adults as Aquipta — its second EU indication.