The AbbVie LUNA study met its primary endpoint after atogepant reduced migraine days during the perimenstrual period more than placebo. AbbVie (NYSE: ABBV) evaluated the preventive treatment in adults across three menstrual cycles.
Participants took atogepant for seven consecutive days beginning three days before the expected start of menstruation. The average reduction was 1.20 migraine days with atogepant compared with 0.40 days for placebo, a difference of 0.80 days.
AbbVie LUNA Study Also Meets Eight Secondary Endpoints
AbbVie said the trial produced statistically significant and clinically meaningful improvements across all eight ranked secondary endpoints. Those measures included headache burden, acute medication use, functional disability, cognitive function and the proportion of patients reaching specified response levels.
Safety findings were consistent with the known profile of atogepant, with no new safety signals observed, according to the company’s investor communications. Topline results provide only a summary, and a fuller assessment will depend on detailed data presented at medical meetings or in a peer-reviewed publication.
AbbVie plans to submit the AbbVie LUNA study results to health authorities worldwide. Regulatory acceptance is not guaranteed, but a successful expansion could give physicians a targeted preventive option for patients whose migraine attacks are closely associated with the menstrual cycle.
