AbbVie reports positive Phase 3 results for atogepant in menstrual migraine

AbbVie has reported positive topline results from the Phase 3 LUNA study of atogepant, a CGRP receptor antagonist, for the preventive treatment of menstrual migraine in adults. The trial enrolled 468 women with pure menstrual migraine or menstrually-related migraine across Europe and Asia.

Atogepant met its primary endpoint, reducing migraine days during the perimenstrual period by an average of 1.20 days versus 0.40 days for placebo, a difference of 0.80 fewer migraine days. It also met all eight ranked secondary endpoints, covering headache burden, acute medication use, functional disability, cognitive function and responder outcomes, with no new safety signals.

AbbVie said it plans to submit the data to health authorities worldwide and present the findings at future medical congresses. Atogepant is marketed as QULIPTA in the US and AQUIPTA in the EU, and is approved in 60 countries.