A host of new drugs that appear to prevent migraine headaches are in the final stages of testing and approval in the United States.<\/p>\n
“What’s really exciting about this is that until this development, we have not had a migraine-specific preventive at all,” said Dr. Peter Goadsby, a professor of neurology at the University of California, San Francisco.<\/p>\n
These are the first drugs to prevent migraine made specifically for migraine patients, said Goadsby. He led a research trial, with findings scheduled for presentation Saturday at an American Headache Society meeting, in Boston.<\/p>\n
The new injectable drugs work by blocking a migraine-related protein called the calcitonin gene-related peptide (CGRP) or the receptor it acts on.<\/p>\n
“CGRP is a small molecule that’s released from pain nerves in the head, and is a key part of the process of migraine,” said Goadsby.<\/p>\n
Migraine is a disabling disease affecting more than 36 million men, women and children in the United States. Besides headache, symptoms can include nausea, sensitivity to light and\/or smells, mood changes, difficulty concentrating and visual disturbances.<\/p>\n
Chronic migraine means headaches occur 15 or more days a month; episodic migraine occurs less frequently.<\/p>\n
Most migraine-preventive drugs in use today have been repurposed from their original use, Goadsby said. These include antidepressants, or drugs to lower blood pressure or prevent seizures, he said.<\/p>\n
They all have side effects, and patients usually pick one based on the side effects they can tolerate, not on the basis of how well it prevents migraine, Goadsby said.<\/p>\n
His research — funded by drug maker Amgen — involved the new drug erenumab. In the phase 3 trial assessing the drug’s effectiveness, nearly 1,000 patients with episodic migraine were randomly assigned to one of two doses of erenumab or placebo for six months.<\/p>\n
Half the patients receiving monthly injections of the higher dose of erenumab experienced a 50 percent reduction in the number of migraines they suffered, Goadsby said. As a result, their quality of life improved, too.<\/p>\n
Goadsby said the drug was well-tolerated. The only side effect was irritation at the site of the injection, which he said quickly went away.<\/p>\n
In separate phase 2 trials testing erenumab’s safety for chronic migraine sufferers, the drug was also tied to fewer attacks.<\/p>\n
Goadsby hopes erenumab will be approved by the U.S. Food and Drug Administration and made available by mid-2018.<\/p>\n
These and other trial results are making news at the American Headache Society meeting.<\/p>\n
“It’s very exciting, It’s been a long time in coming,” said Dr. Noah Rosen, director of Northwell Health’s Headache Center in Great Neck, N.Y.<\/p>\n
Anybody who deals with headache patients spends a lot of time explaining why heart medication, antidepressants and anti-seizure drugs are used to prevent migraine instead of headache medications, he said.<\/p>\n
“This is a revolution,” Rosen said. “What triptan medications like Imitrex did for the acute treatment of migraine, this will do for the prevention of migraine.”<\/p>\n
While erenumab works by blocking the receptor CGRP acts on, other drugs work by blocking CGRP itself. They include fremanezumab by Teva; eptinezumab from Alder Biopharmaceuticals, and galcanezumab from Eli Lilly and Co.<\/p>\n
For these three medications, researchers reported results of phase 2 trials that tested the drugs’ safety.<\/p>\n
In each case, patients reported more headache-free days. And side effects, such as changes in blood pressure or potential liver damage, were found not to be a problem, researchers said.<\/p>\n
In addition, the drugs started working the first week of treatment. In some cases, patients were also able to cut back their other medications, researchers found.<\/p>\n
These drugs will need to go through larger phase 3 trials to evaluate their effectiveness before they can be considered for FDA approval.<\/p>\n
Goadsby said the overall outlook is promising for migraine sufferers.<\/p>\n
“There is light on the horizon, which is entirely new and specifically designed for them,” he said. “So for the person who is completely frustrated . . . it’s really going to change.”<\/p>\n
Data and conclusions presented at meetings are usually considered preliminary until published in a peer-reviewed medical journal.<\/p>\n","protected":false},"excerpt":{"rendered":"
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