AbbVie (NYSE: ABBV), a United States-based pharmaceutical company, announced on Friday an interim evaluation of an ongoing Phase three, open-label 156-week extension study assessing the long-term safety and tolerability of oral atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, intended for the prevention of migraine in subjects with chronic or episodic migraine.

The company says that 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. The extension study included participants who had enrolled in the Phase 3 PROGRESS and ELEVATE clinical trials with a baseline monthly migraine day burden of 14.5 days and completed these studies.

Atogepant is also called QULIPTA in the United States and AQUIPTA in the European Union (EU).

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