Eli Lilly announces head-to-head study comparing once-monthly Emgality with every-other-day Nurtec ODT for the preventive treatment of migraine.

CGRP is a protein in the brain thought to play a key role in migraine. Emgality binds to this protein, preventing it from attaching to the CGRP receptors, whereas Nurtec ODT blocks the receptor for this protein. This study aims to answer important questions that will help clinicians and patients make more informed treatment decisions on the path to more migraine-free days. The study, which is the first head-to-head clinical trial comparing two medications targeting CGRP, is a multi-site, randomized, double-blind, double-dummy, parallel-group Phase IV study in patients who meet the International Classification of Headache Disorders (ICHD) criteria for a diagnosis of episodic migraine with or without aura. There will be two treatment arms: Emgality 120 mg once-monthly injection, with an initial 240 mg loading dose, and Nurtec ODT 75 mg, taken every other day. The study's primary endpoint is 50% reduction in monthly migraine headache days. Enrollment is expected to begin later this year. "The American Headache Society and the National Headache Foundation have endorsed several goals that raise the treatment outcomes bar for preventive migraine medications. Patients tell us they want an easy and convenient migraine treatment that can help them be productive and free to focus on what matters most to them. In order for patients to manage their own disease and have a sense of personal control, they need to find treatments that work for them that they can stay on. Reducing the number of days patients experience migraine is possible and it's important that patients and their HCPs talk about this as a goal," said Dr. Merle Diamond, managing director of the Diamond Headache Clinic and longstanding board member of the National Headache Foundation. "Undertaking this head-to-head study signals Lilly's confidence in Emgality, a once-monthly injectable monoclonal antibody CGRP antagonist (CGRP mAb), as it compares to Nurtec ODT, a small molecule oral CGRP receptor antagonist (gepant), for the prevention of migraine."