AbbVie has reported positive results from its menstrual migraine drug “Atogepant”. It has met the primary endpoint and all eight ranked secondary endpoints in the Phase 3 LUNA study.
The AbbVie menstrual migraine drug trial tested atogepant as a preventive menstrual migraine treatment in adults and found a greater reduction in migraine days around menstruation compared with placebo.
AbbVie plans to submit the atogepant drug trial results to health authorities worldwide.
About AbbVie’s Menstrual Migraine Drug Atogepant
Atogepant is an oral CGRP receptor antagonist. CGRP is a molecule involved in a biological pathway associated with migraine, while receptor antagonists work by blocking that pathway.
Atogepant is already approved for migraine prevention in adults in multiple markets. AbbVie markets the medicine as QULIPTA in the United States and several other countries and as AQUIPTA in the European Union. It is currently approved in 60 countries.
However, the positive results for the AbbVie menstrual migraine drug trial do not mean atogepant is already approved specifically for menstrual migraine.
AbbVie Menstrual Migraine Drug Trial Meets Main Goal
The AbbVie atogepant drug trial, known as the LUNA Phase 3 study, enrolled 468 adult female participants with pure menstrual migraine or menstrually related migraine, with or without aura. Researchers conducted the randomized, double-blind, placebo-controlled study across sites in Europe and Asia.
Participants took atogepant for seven consecutive days, beginning three days before the expected start of menstruation, over three menstrual cycles. Researchers measured changes in migraine days during the perimenstrual period, which refers to the time around menstruation.
The AbbVie atogepant drug Phase 3 trial found:
- 1.20 fewer migraine days with atogepant on average
- 0.40 fewer migraine days with placebo
- 0.80 fewer migraine days with atogepant compared with placebo
- A statistically significant result of p<0.0001
AbbVie Atogepant Drug Trial Shows Improvements Beyond Migraine Days
The AbbVie menstrual migraine drug trial also met all eight ranked secondary endpoints. These measures examined several aspects of the disease beyond the number of migraine days.
The secondary endpoints included measures of:
- Headache burden
- Acute medication use
- Functional disability
- Cognitive function
- Responder outcomes
AbbVie reported statistically significant and clinically meaningful improvements versus placebo across all eight ranked secondary endpoints. Safety findings were consistent with the known safety profile of atogepant, and the company reported no new safety signals.
“These data bring us closer to our goal of bringing a potential treatment option for women living with this debilitating disease,” said Primal Kaur, M.D., AbbVie’s senior vice president of global development.
Significance of AbbVie Menstrual Migraine Drug Trial Results
Menstrual migraine involves recurrent migraine attacks that occur around or during menstruation. These attacks can be severe and disruptive, while some people report that they last longer or respond less effectively to medication than non-menstrual migraine attacks.
The need for a dedicated menstrual migraine drug remains significant. Data from the European Migraine and Headache Alliance show that 68% of surveyed women had never been offered a tailored treatment approach for menstrual migraine. Separately, the CaMEO-I study found that 66% of eligible respondents reported migraine attacks around menstruation.
Cristina Tassorelli, M.D., Ph.D., professor of neurology at the University of Pavia, said menstrual migraine attacks are generally more severe and harder to treat. She described LUNA as the first study of a CGRP-targeted treatment to report positive results specifically in menstrual migraine.
AbbVie Plans Regulatory Submissions for QULIPTA
Following the positive LUNA results, AbbVie plans to submit the data to health authorities worldwide and present the findings at future medical congresses. A more detailed readout is expected at an upcoming medical conference.
The potential expansion would give QULIPTA menstrual migraine drug another role in migraine prevention if regulators approve it.
For now, the AbbVie menstrual migraine drug trial provides Phase 3 evidence supporting further regulatory review.
The findings, therefore, are an important development for a patient population that has lacked a treatment specifically approved for menstrual migraine.
