Atogepant Effective for Migraine Prevention

Results of the phase 3 ADVANCE clinical trial (NCT03777059) evaluating atogepant (AbbVie; Chicago, IL) for migraine prevention have been published in The New England Journal of Medicine. Treatment with atogepant vs placebo resulted in a statistically significant reduction in mean monthly migraine headache days (MMD) in participants with episodic migraine.  

Participants, who had 4 to 14 MMD, treated with 10 mg, 30 mg, or 60 mg of atogepant had respective mean MMD decreases of 3.7, 3.9, and 4.2 days compared with a decrease of 25 days in those treated with placebo. In those receiving 10 mg, 30 mg, or 60 mg atogepant, 55.6%, 58.7%, and 60.8%, respectively, achieved a 50% or greater reduction in MMD, compared with 29.0% of those who received placebo. Improvements were also seen on the Activity Impairment in Migraine–Diary (AIM-D) with the 30-mg and 60-mg doses of atogepant vs placebo.

“The novel AIM-D functional scale administered in the ADVANCE study and the Migraine-Specific Quality of Life Questionnaire helped us monitor the effects of migraine on ability to perform daily activities and functions,” said Peter Goadsby, MD, neurologist and professor, University of California at Los Angeles and King’s College, London. “These data, along with the primary endpoint and other secondary endpoints, help further our understanding of atogepant as a potential treatment option for people living with migraine.”  

All doses were well-tolerated. The most common adverse events reported with a frequency ≥ 5% in at least 1 atogepant treatment arm, and greater than placebo, were constipation (6.9-7.7% across all doses), nausea (4.4-6.1% across all doses), and upper respiratory tract infection (3.9-5.7% across all doses). Most cases of constipation, nausea, and upper respiratory tract infection were mild or moderate in severity and did not lead to discontinuation.

Atogepant is an investigational, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) which, if approved, will be the first and only oral gepant specifically developed for the prevention of episodic migraine.