Practical Pain ManagementFDA Expands Approval of Oral Agent for Migraine

FDA’s New Approval of Atogepant for Chronic Migraine Prevention is a Breakthrough in Migraine Management

A promising breakthrough in migraine management, the FDA’s new approval of atogepant tablets, brings renewed hope for chronic migraine sufferers. According to AbbVie, this endorsement allows the use of atogepant (Qulipta) in the prevention of chronic migraines in adults.

Atogepant stands out as the first oral calcitonin gene-related peptide (CGRP) receptor antagonist to receive dual approval for episodic and chronic migraines. It works by blocking CGRP, a molecule involved in transmitting pain signals. Chronic migraines, to clarify, involve enduring headaches for at least 15 days a month, with eight of those days associated with migraines.

Before this, in September 2021, the FDA approved atogepant for treating episodic migraines. Patients can take the drug in 10 mg, 30 mg, and 60 mg dosages. The FDA recommends the 60 mg dose for chronic migraine patients.

Peter McAllister, MD, from the New England Center for Neurology and Headache, noted that the FDA’s endorsement offers a new, convenient daily treatment for chronic migraine patients. The demonstrated efficacy and functional improvement of atogepant make it an appealing option for neurologists and headache specialists when devising treatment plans for patients.

The FDA based its decision on the findings from the Phase 3 PROGRESS trial. This trial included 778 chronic migraine patients. Researchers gave the participants either 60 mg of atogepant daily, 30 mg twice daily, or a placebo for 12 weeks. The aim was to decrease the average monthly migraine days. They found that atogepant users experienced a significant decrease in mean monthly migraine days compared to the placebo group.

Moreover, after 12 weeks, atogepant users reported significant improvements in daily function and physical activity, as indicated by the Activity Impairment in Migraine-Diary (AIM-D) scores. They also expressed an improved quality of life, as measured by the Migraine Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1), after 12 weeks of treatment.

However, atogepant isn’t for everyone. It’s not recommended for those with kidney or liver problems, people on dialysis, or women who are pregnant, planning to become pregnant, or breastfeeding. Those with a hypersensitivity to atogepant or its components should also avoid this medication. The common side effects include nausea, constipation, and fatigue.

Finally, atogepant joins the ranks of several other CGRP receptor antagonists available on the market, with oral options such as ubrogepant and rimegepant and injectable alternatives including erenumab, fremanezumab, galcanezumab, and eptinezumab-jjmr.