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People who have tried unsuccessfully to prevent migraine with other treatments may find relief with a new drug, according to a preliminary study released Tuesday.
Erenumab is part of new class of drugs —fully human monoclonal antibodies — that block calcitonin gene-related peptide (CGRP), a molecule that transmits migraine pain signals during an attack. The medication is a long-lasting injection that is meant to stop a migraine before it even starts.
“If we can block CGRP, then we can abort a migraine attack,” said Dr. David Kudrow, director of the California medical clinic for headache, who was not involved in the study.
More than thirty-seven million Americans suffer from migraine attacks, according to the American Headache Society. Of these, about 4 million have chronic migraine and suffer headaches for 10 to 14 days a month.
While some people are helped by low cost, over-the-counter drugs such as ibuprofen, others need stronger prescription medications, such as sumatriptan and ergotamine, which constrict the blood vessels in the brain and can cause dizziness or nausea. Botox injections are also used to help ease migraines in some people.
But a large percentage of sufferers are not helped by anything.
"This is the first-ever mechanism specific migraine drug designed for prevention," said lead study author Dr. Peter Goadsby, professor of neurology at Kings College London, UK and University of California, San Francisco. "This will change migraine treatment for those who don’t respond to conventional treatments.”
To participate in the study — the results were released ahead of the annual meeting of the American Academy of Neurology — adults ages 18 or over, had to report between four and 14 disabling episodic migraines, or 15 or more chronic migraines per month, and to have failed two or more preventative treatments, such as topiramate, propranolol, or amitriptyline.
Researchers found that the drug reduced the average number of monthly migraine headaches by more than 50 percent for nearly a third of study participants. After three months, patients treated with the human antibody were nearly three times more likely to have reduced their migraine days by 50 percent or more, than those treated with placebo.
They also had a greater average reduction in the number of days with headaches and the number of days they needed to take drugs to stop the migraines.
No patients taking erenumab stopped treatment due to adverse side effects, but the scientists noted that more research will needed to investigate if the benefits continue.
Malden, Massachusetts native Denise Desjardins, 58, coped with migraine headaches for over 10 years, particularly around her menstrual cycle.
“I would land in bed for two to three days, four to five times a year,” said Desjardins. “These were in-your-bed, no-matter-what headaches.”
This will change migraine treatment for those who don’t respond to conventional treatments
Dr. Peter Goadsby
Her migraines became a daily misery after a bilateral mastectomy following a diagnosis of breast cancer. She was put on Imitrex, a popular migraine drug that helps to quiet overactive pain nerves in the brain, but it didn't help.
For about four years, Desjardins has been taking an erenumab injection once a month, without any side effects, as part of the study.
"I don't even think I get migraines anymore," said Desjardins.
The drug is expected to receive Food and Drug Administration approval on May 17. If approved, it could be available for prescription, and insurance coverage, later this year. The drug's cost has been estimated at $10,000 a year.
Because other migraine medications were not developed for headache, their side effects limited how well patients could tolerate them, said Kudrow.
"This class of drug is a real game changer," said Kudrow. "One, because it’s effective and two, the side effect profile is really favorable."