AbbVie’s Qulipta has become the first oral CGRP inhibitor to show success in a phase 3 trial for menstrual migraine, a condition frequently resistant to current therapies. Already a leading product for episodic and chronic migraine prevention, the medication may now target a large, underserved population. Qulipta generated over $2.3 billion in annual revenue following its approval for broader migraine prevention, positioning it as a key asset in AbbVie’s neuroscience portfolio.
The LUNA study evaluated Qulipta (atogepant) in 468 women experiencing menstrual migraines. Participants took the drug for seven consecutive days—beginning three days before menstruation, across three cycles. Preliminary findings revealed an average reduction of 1.20 migraine days with Qulipta versus 0.40 days with placebo, a statistically significant improvement of 0.80 days. While AbbVie did not release secondary endpoint details, they confirmed those metrics were achieved, reinforcing the drug’s potential as a dedicated menstrual migraine therapy.
Menstrual migraine impacts roughly 12 million women in the U.S., with research indicating up to two-thirds of women with regular migraines endure cycle-related attacks. These episodes often prove more severe, prolonged, and difficult to manage than general migraines. Survey data from the European Migraine and Headache Alliance further highlights that 68% of women with menstrual migraines reported never receiving treatment specifically designed for their condition, showing a critical gap in therapeutic options. The condition’s severity, characterized by longer-lasting, more resistant attacks, contributes to its disproportionate impact on women’s quality of life.
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If regulatory approval follows, Qulipta would enter a market with few alternatives. Pfizer’s Nurtec ODT (rimegepant) is also in late-stage testing for menstrual migraine, but no other oral CGRP inhibitors have demonstrated effectiveness in this area. AbbVie intends to present the data to health authorities to pursue label expansion, which could solidify Qulipta’s dominance in a segment where competition remains limited.
Menstrual migraine contributes significantly to why women experience migraines at nearly three times the rate of men. The condition’s treatment resistance has left many patients without adequate relief. AbbVie’s results indicate Qulipta could address this gap, though its adoption hinges on regulatory decisions and competition from Pfizer.
Primal Kaur, AbbVie’s head of global development for immunology, neuroscience, eye care, and specialty medicines, described the findings as progress toward tackling a “disabling condition.” “Menstrual migraine attacks can be severe, long-lasting, and disruptive to daily life,” commented Kaur. “[This] data bring[s] us closer to our goal of bringing a potential treatment option for women living with this debilitating disease,” she added.
