Atogepant Cuts Migraine Days in Patients With Prior Treatment Failure

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Atogepant is an oral calcitonin gene-related peptide receptor antagonist.

Treatment with atogepant resulted in a statistically significant reduction in mean monthly migraine days in patients with episodic migraine who previously failed 2 to 4 classes of oral prophylactic treatments, according to data presented at the 2023 American Academy of Neurology Annual Meeting.

Atogepant (Qulipta®), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, is currently approved by the Food and Drug Administration for the preventive treatment of migraine in adults. The ELEVATE study ( Identifier: NCT04740827) was conducted to assess the effectiveness of the treatment in patients with episodic migraine who failed oral migraine prophylaxis medications from 2 to 4 medication classes. A total of 309 patients were enrolled in the study; 56% had previously failed 2 classes of medications and 44% had failed 3 or more classes.

Study participants were randomly assigned to receive atogepant 60mg once daily or placebo. The primary endpoint was the change from baseline in mean monthly migraine days (MMDs) across the 12-week treatment period.

Results showed that patients treated with atogepant 60mg once daily experienced a significant decrease in MMDs of 4.20 days compared with a reduction of 1.85 days with placebo (P <.0001). Atogepant was also associated with significant improvement in all secondary endpoints including achievement of more than 50% reduction in MMDs, change from baseline in MMDs, and change from baseline in acute medication use days across 12 weeks. The most commonly reported adverse events that occurred with greater frequency in the atogepant arm included constipation and nausea.

“We understand that people living with migraine endure a chronic neurological disease and we are dedicated to providing them the best chance to live a life with less frequent migraines,” said Dawn Carlson, vice president, neuroscience development, AbbVie. “The data presented at AAN underscores the important role of atogepant, not only as a treatment option for people living with episodic migraine but also for those whose previous treatments failed to help reduce the impact of migraine on their lives.”


AbbVie announces late-breaking results from phase 3 trial evaluating atogepant (Qulipta®) for the preventive treatment of episodic migraine among patients with prior treatment failure at the 2023 AAN Annual Meeting. News release. April 21, 2023.