Migraine headaches are a significant health problem for millions of people. In the United States, estimates put the number at 37 million people who experience migraines.
About 5 million of those sufferers will have at least one acute migraine attack each month, and nearly 11 million people have a moderate to severe disability as a result of their migraines. They are more common in men than in women and occur most often in patients aged 35 to 55 years old.
Help may be on the way for some patients. A six-month Phase 3 study of a new drug called erenumab, developed by Amgen in Thousand Oaks CA, showed results that are very promising. The drug is being tested as a migraine preventative. While there are medications already approved to treat migraines once they have started, drugs that can prevent migraines have been more difficult to research
In the study recently published in the New England Journal of Medicine, participants who suffered from episodic migraines, which means between 4 and 14 migraine days per month, were given either erenumab or a placebo. Patients who received the erenumab had less mean days of migraine pain per month compared to the placebo group. For the research, patients reported how they felt and the frequency of migraines via the Migraine Physical Function Impact Diary, which is designed to help patients report how their headaches impact physical functioning. Erenumab which will go by the trade name Aimovig once on the market is the first medication of its kind. It’s a fully human monoclonal antibody that involves receptors for certain genes. It’s made to block the calcitonin gene-related peptide (CGRP) receptor. Previous migraine research shows that the CGRP receptor is a crucial part of activating migraines. The hope is that this medication can stop a migraine before it starts.
The STRIVE study (Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention) enrolled 955 patients experiencing a mean baseline of 8.3 monthly migraine days. The participants were randomly assigned to three groups. One group took a placebo, one group received 70mg of Aimovig, and the third group took a higher dose of 140mg of the drug. Those that took the 70mg dose had 3.2 fewer migraine days per month, and the group at 140mgs had a reduction in migraine days of 3.7 days per month. In the group taking the placebo, the reduction in days was 1.8.
Sean E. Harper, M.D., is the executive vice president of Research and Development at Amgen and he stated, "There is a clear unmet need for efficacious, innovative therapies for the prevention of a migraine. Publication of these data underscores the significance of the CGRP receptor blocker Aimovig as potentially the first available treatment targeting a pathophysiologically relevant pathway for one of the most common causes of disability across the globe. We look forward to advancing our robust clinical program for Aimovig in order to help ease the burden of this devastating disease and to best support the migraine patient community."
The study also showed that patients who took Aimovig had less need of migraine “rescue” drugs that are used to treat an episode once it has begun. These patients also reported being better able to go about their daily chores around the house, getting dressed and ready for their workday and engaging in activities that required concentration. The video posted here has more information about the trial and what it could mean for millions of migraine patients.