- Researchers report that a new migraine drug performed well in a recent clinical trial.
- The drug ubrogepant stopped migraine pain within 2 hours of being taken by some participants.
- Experts say the new drug isn’t a “cure-all,” but if approved it could be an important tool in a doctor’s medical kit.
A new migraine medication has shown promising results in a successful large-scale clinical trial.
The drug, called ubrogepant, performed better than a placebo and has fewer risks than other drugs, researchers are reporting.
Within 2 hours of being taken in a clinical trial, researchers say ubrogepant was able to completely stop a severe migraine attack.
The researchers
Experts say having more options for the acute treatment of migraine will be beneficial to the millions of people who live with the condition and receive no relief from other treatment options.
“It’s great to have another treatment option for migraine attacks. We currently have several different treatment options for the acute treatment of an attack, and the method for measuring acute treatment options is that 2 hour pain freedom. That is the typical design of an acute migraine attack trial,” Amaal J. Starling, MD, assistant professor of neurology in the division of headache at Mayo Clinic Hospital in Phoenix, Arizona, told Healthline.
“The reason we need to have more treatment options is because 30 to 40 percent of patients don’t respond to our currently available treatment options. I’m hoping this treatment option will be able to address at least a part of that 30 to 40 percent,” she said.
In the United States, 39 million people live with migraine. The neurological disease affects more women than men, with around 28 million women having migraine.
In addition, about 85 percent of people with chronic migraine — those who experience at least 15 days per month with a migraine attack — are women.
Migraine is much more than a bad headache and can cause significantly incapacitating neurological symptoms. Those experiencing a migraine attack often have throbbing, severe pain, typically on one side of the head.
In a third of cases, the throbbing pain is on both sides. Pain can be accompanied by nausea, vomiting, and dizziness; sensitivity to light, sound, smells, and touch; or numbness in the face or extremities.
Attacks can last between 4 and 72 hours.
Treatment options vary between individuals, but for those with severe migraine, options are limited. Surveys show that less than a third of those with migraine were satisfied with their care.
Starling argues this is in part due to stigma preventing migraine research getting adequate funding.
She notes that the National Institutes of Health provides about $20 million of research funding for an ailment that affects nearly 40 million people in the United States.
“This disease is the second-leading cause of disability worldwide, so it just doesn’t make sense,” Starling said.
“It comes down to stigma. People don’t consider migraine a real neurologic disease. People don’t consider migraine to be something that would be worthwhile spending funding on. If you don’t have funding, you don’t have research. If you don’t have research, you don’t have enough treatment options. If you don’t have enough treatment options, doctors don’t take it seriously. That just perpetuates the stigma,” Starling said.
She says she hopes the latest research will reverse this trend.
“I’m hoping with the development of these new medications and new treatment options that we can start validating and legitimizing this disease process to break the stigma so that more safe, disease-specific treatment options can be offered,” she said.
Since the 1990s, the most popular form of migraine medication when over-the-counter pain relief fails is triptans.
These drugs work by stimulating serotonin in the brain to restrict blood vessels, reduce inflammation, and stop headaches.
Due to the constriction of blood vessels, triptans are unsafe for people who have a high risk for heart attack or stroke.
Michael A. Rogawski, MD, PhD, a professor of neurology at the University of California, Davis School of Medicine, says triptans can also lead to other problems.
“A major disadvantage of the current acute migraine treatments, especially those in the triptan category, is overuse. If the medications are used too frequently, patients may experience worsening of their migraine with more frequent attacks,” Rogawski told Healthline.
However, drugs such as ubrogepant work in a different way.
This class of drugs are called CGRP receptor antagonists and target a molecule called CGRP that has a recognized role in migraine.
“The information we have to date is that the small molecule CGRP receptor antagonists don’t have this problem. Even if they are used frequently, medication overuse doesn’t seem to occur,” Rogawski said.
So far, the Food and Drug Administration has approved three CGRP inhibitors drugs, all of which are injections.
If ubrogepant is approved, it will be one of the first oral forms of this drug that can prevent acute migraine attacks.
“If it holds up, it will be exciting to have acute migraine treatments that can be used even by people who have very frequent migraine attacks,” Rogawski said.
“I often see such patients in my practice, and it’s frustrating to have to advise them not to use the medication more than two times a week. We very likely won’t need to place this restriction on drugs such as ubrogepant,” he said.
Experts say ubrogepant shouldn’t be considered a cure-all for people with migraine, but it provides a helpful alternative for cases that don’t respond to currently available treatments.
“The results are good but not superior to triptans and NSAIDs,” Morris Levin, MD, director of the Headache Center at University of California, San Francisco Medical Center, told Healthline.
“It looks like a good new alternative for treating migraine attacks. I think it will be a very useful addition to our toolbox,” Levin said.
Lauren Green, DO, RD, clinical assistant professor of neurology at Keck School of Medicine at the University of Southern California, says the drug may be good news for those who are yet to feel relief from other medications.
“The patients that could benefit the most from new therapies are the chronic migraine patients, the ones that have suffered for years without relief,” she said.
Starling believes in her lifetime there will be enough treatment options to address every person with migraine, both from a preventive treatment perspective and an acute treatment perspective.
“Due to genetic heterogeneity or variability, everyone’s migraine disease is a little different, which is why it’s so important to have different treatment options for the many different patients,” she said.