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A drug approved to prevent migraines has now reached a promising late-stage milestone for menstrual migraines.
This Migraine Condition Affects 1 in 3 Women. A Treatment Just Met a Phase 3 Goal
Author: Lucia Auerbach
One of the country’s largest pharmaceutical companies announced last week that a new menstrual migraine treatment met a late-stage study goal.
AbbVie, the biopharmaceutical company best known for Skyrizi and Botox, said that in a late-stage study, its migraine treatment reduced the number of migraine days associated with the menstrual period, according to the company’s release.
The drug, atogepant (sold under the brand name Qulipta), has been approved in 60 countries, including the U.S., as a preventive treatment for migraines in adults.
Atogepant met the main goal of the Phase 3 LUNA study, showing a greater reduction than the placebo in migraine days during the perimenstrual period when averaged across three menstrual cycles.
Menstrual migraines are differ from other migraines because of their timing.
Primal Kaur, senior vice president of global development, immunology, neuroscience, eye care and specialty at AbbVie told Inc. that menstrual migraines predictably occur around menstruation, when hormonal fluctuations occur. The attacks may be more severe and longer lasting than attacks during other cycle times.
Research published by Georgetown University in 2024 found that one-third of women suffer from menstrual migraines.
Currently, there are no treatment options approved for menstrual migraines. This finding underscores the need for more approaches to care for people with the condition.
“The lack of data around menstrual migraine attacks speaks to the high unmet need that exists for these women,” Kaur told Inc. “Recognizing this type of migraine can support more individualized care.”
There are typically four main phases that drugs must go through. Atogepant reaching the endpoint of Phase 3 suggests that a potential future treatment option may not be too far away.
Positive Phase 3 results
The study evaluated participants who took atogepant for seven consecutive days, starting three days before the beginning of their monthly period. Participants repeated the regimen over the course of three menstrual cycles.
The average reduction was 1.2 days for those taking atogepant compared with 0.4 days for those taking the placebo, corresponding to 0.8 fewer migraine days versus the placebo. The drug also was found to make meaningful improvements against the placebo across eight secondary endpoints, including functional disability, cognitive function, and measures of headache burden.
“The reduction is clinically relevant because menstrual migraine attacks occur during a predictable, concentrated window and can significantly disrupt daily life,” Kaur told Inc. “Improvements across secondary outcomes, including responder rates, acute medication use and functional measures, further support the potential clinical relevance of the findings.”
Kaur said that the study’s full results will be presented at future scientific meetings and published in a peer-reviewed journal.Credits: TCA, LLC.