AbbVie announced an interim analysis of an ongoing Phase 3, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine.

The overall long-term safety results were consistent with the known safety profile of atogepant in chronic and episodic migraine, and no new safety signals were identified. These results also support improvements in key efficacy outcomes, including reduction in monthly acute medication use days.

"Migraine is a debilitating neurological disease that can have a significant impact on day-to-day life," said Sait Ashina, MD, assistant professor of neurology and anesthesia at Harvard Medical School, director of the Comprehensive Headache Center at Beth Israel Deaconess Medical Center in Boston, and lead author of the study.

"As the first report of one-year atogepant data in patients with chronic migraine, this builds on the long-term observed safety and efficacy in the episodic migraine population and demonstrates atogepant's ability to reduce migraine days and acute medication use across the spectrum of the disease."

"We understand that migraine is a complex disease and AbbVie is steadfast in our commitment to alleviating the considerable burden facing migraine patients," said Dawn Carlson, vice president, neuroscience development, AbbVie. "Patients should accept nothing less than migraine freedom, and the long-term safety and efficacy shown in this interim analysis marks another step toward that goal." 

AbbVie will continue to pursue additional regulatory submissions for atogepant across international markets.