Atogepant Safe, Effective in the Preventive Treatment of Migraines

All active treatment arms of atogepant in the phase 3 ADVANCE trial, evaluating the drug for the preventive treatment of migraine in adults, met their primary endpoint of a statistically significant reduction in mean monthly migraine days across the 12-week treatment period compared to placebo. A greater proportion of atogepant-treated participants achieved at least a 50% reduction in mean monthly migraine days for all doses compared to placebo, according to the 12-week results of the trial published in the New England Journal of Medicine.

“Too many people around the world face the incapacitating challenges of migraine, which place undue burden on patients, care partners, and health systems,” said Michael Gold, MD, vice president of neuroscience development at AbbVie, in a press release. “At AbbVie, we are resolutely committed to advancing new treatment options across the migraine continuum. These data reinforce our confidence in atogepant as a potential option for the preventive treatment of migraine.”

The phase 3 ADVANCE study was a randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the preventive treatment of migraine in those with 4 to 14 migraine days per month. The study enrolled a total of 910 patients, randomized into 4 treatment arms. These included evaluations of 10 mg, 30 mg, and 60 mg of atogepant once daily, as well as a placebo group.

According to the investigators, patients treated in the 10 mg, 30 mg, and 60 mg atogepant arms experienced a decrease of 3.7, 3.9, and 4.2 monthly migraine days, respectively, compared to patients in the placebo arm. Patients receiving placebo experienced a decrease of 2.5 days. Further, over the 12-week treatment period, 55.6%, 58.7%, and 60.8% of patients in the 10 mg, 30 mg, and 60 mg atogepant arms, respectively, achieved a 50% or greater reduction in monthly migraine days, compared to 29.0% of patients in the placebo arm.

Patients receiving atogepant also had significantly greater improvements in the Migraine-Specific Quality of Life Questionnaire version 2.1 Role Function-Restrictive domain score at all dosage levels compared to placebo, according to the investigators. Improvements were also observed in the mean monthly AIM-D** Performance of Daily Activities domain score compared to placebo for patients receiving the 30 mg and 60 mg doses.

“Migraine symptoms can vary in frequency and severity from person to person and from attack to attack, which is why they can impact people's daily lives in so many different ways,” said Peter Goadsby, MD, neurologist and professor at UC Los Angeles and King's College, London, in the release. "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. 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 dosage levels were well tolerated, with the most common adverse events (AEs) including constipation, nausea, and upper respiratory tract infection. The majority of these AEs were mild or moderate in severity and did not lead to discontinuation.

REFERENCE

New England Journal of Medicine publishes 12-week results from study evaluating atogepant for the preventive treatment of migraine [news release]. AbbVie; August 18, 2021. Accessed August 19, 2021. https://news.abbvie.com/news/press-releases/new-england-journal-medicine-publishes-12-week-results-from-study-evaluating-atogepant-for-preventive-treatment-migraine.htm