By Gene Emery
(Reuters Health) – Two drug trials may promise some relief for people who suffer migraine headaches as well as those who have cluster headaches, a rare but intensely painful type of headache thought to be related to migraine.
According to a study in the New England Journal of Medicine, two injections of the drug galcanezumab reduced the frequency of episodic cluster headaches (ECH). And in a separate study in the same issue of the journal, an experimental oral drug made migraine pain quickly go away for 1 in 5 sufferers.
Cluster headaches typically appear at least once a day – often at the same time of the day or night – for weeks or months. The pain is typically around one eye. They eventually go away for a while but can return after an absence of months or years.
In the galcanezumab study, 106 volunteers received two injections of the anti-migraine medicine or a placebo, spaced one month apart. The drug cut the average number of episodic cluster headaches by 51% during the first 3 weeks of treatment, from 17.8 per week down to 9.1 per week. Placebo injections produced a 30% reduction, from 17.3 per week to 12.1 per week. Almost three quarters of participants saw some reduction in headache frequency compared to about half of those on placebo.
“Some patients get completely suppressed and many partially so,” lead author Dr. Peter Goadsby of King’s College London told Reuters Health in an email. “I do not think one can overstate how bad a cluster attack is.”
To be eligible for the study, patients had to have at least one attack every other day but not more than eight per day. The typical volunteer had been dealing with the headaches for more than 16 years. The average age was about 46 years old and more than 82% were men.
Each 300 mg injection costs about $1,400, according to the website goodrx.com. Galcanezumab is sold under the brand name Emgality by Eli Lilly, and the company paid for the study.
“Patients report ECH attacks as the most severe pain they experience – bar none,” including childbirth and kidney stones, said Dr. Goadsby, director of the NIHR-Wellcome Trust King’s Clinical Research Facility and SLaM Biomedical Research Centre.
“Imagine what it’s like to give birth 1-8 times a day, every day, for 8-12 weeks a year. Imagine not a single full night’s sleep for 8-12 weeks and you know next year, it will be the same,” he said. “This development is really important for these patients.”
And it may spark the development of treatments that are even more effective, he added.
The U.S. Food and Drug Administration approved the drug as a first-ever treatment for episodic cluster headaches in June. The company estimates that about one quarter of a million people in the United States suffer from them.
In contrast, migraine headaches plague about 39 million people in the U.S., or up to 14% of the population, primarily women. Three quarters of people who have migraines experience at least one per month.
The migraine study looked at Biohaven Pharmaceuticals’ experimental oral drug rimegepant, and was financed by Biohaven.
Researchers found that 19.6% of the 537 volunteers who took it while suffering from a migraine were free of pain within two hours compared to 12% of the 535 volunteers given placebo.
Half the patients in both groups had their pain relapse 2 to 48 hours after the dose. Unlike conventional treatment with triptan drugs, taking a second dose doesn’t provide additional relief, lead author Dr. Richard Lipton, director of the Montefiore Headache Center in New York City told Reuters Health in a telephone interview.
“Triptans are well-established therapies; maybe 25% of people with migraines are currently on a triptan,” said Lipton, who is also in the department of neurology at the Albert Einstein College of Medicine. “If it works well for them, they’re not going to be candidates on this drug. This is for people with contraindications for a triptan” or people who get no relief from triptans.
Triptan therapy costs about $7,000 a year, he said, and when it comes to rimegepant, “I’m very hopeful the drug will be affordable because there are a lot of people who need it.”