New, long-acting drugs may hold an answer to millions of people who often suffer migraines. Research of two of these medicines, given as shots each month roughly, found they cut the frequency of the notoriously unpleasant and disabling headaches.
The drugs are the 1st preventive drugs developed particularly for migraines. They function by interfering with a substance involved in altering nerve signalling and progression of pain and symptoms.
“It’s a whole new direction” for treatment and a significant advance for patients who don’t want to take or aren’t helped by the daily pills sometimes used now to avoid recurrences, said Dr Andrew Hershey, neurology chief at Cincinnati Children’s Hospital Medical Center.
He had no role in the study but has tested other migraine drugs and wrote a commentary published in the studies Wednesday by the New England Journal of Medicine.
Migraines plague more than a billion people worldwide, more than 38 million in the U.S. alone. They’re more severe than a regular headache – throbbing, squeezing pain and pressure, frequently accompanied by vision complications, sensitivity to light, noise or smells, and nausea. They can leave people struggling to work or do basic things such as cooking or even hold a conversation.
WHAT THE STUDIES SHOW
One study tested erenumab (er-EN-yoo-mab), from Amgen and Novartis, in about 900 people who averaged eight migraines monthly. Nearly half had already tried other preventive medicines.
For 6 months, they were given monthly shots into the abdomen of a high dose of the drug, a low dose or a dummy medicine. The number of days they suffered migraines every month dropped by 3 to 4 in the drug groups and almost 2 in the placebo group. Half of the patients on the higher dose saw their migraine days lower at least by 50 %.
“I very definitely benefited,” said Anne Vickers, who got the lower dose through one of the study leaders at Mercy Hospital St. Louis in Missouri.
“I can have anywhere from 15 to 18 headaches per month, and probably five of those days are migraines,” but that dropped 40 % on the medication, she said. “I have 3 kids, so for me, it meant having more days when I was able to live my everyday life, cook a meal at home, go to events at school.”
The second study tested fremanezumab (frem-uh-NEZZ-yoo-mab), from Teva Pharmaceutical, for a chronic migraine, defined as headaches on 15 or more days monthly, at least eight of them migraines.
About 1,000 patients received monthly shots for 3 months: 1 / 3 got the drug every time, another third got the drug the 1st time and dummy shots another two times, and the others got dummy shots every time.
Monthly headache days dropped by 4 to 5 in the groups given the drug and by 2 to 3 for those given dummy treatments.
Average reductions of 1 or 2 days per month are modest, but “there are some patients who have had a complete response – they become headache-free,” Hershey said.
No worrisome side effects emerged, however, the studies were fairly short, so long-term safety and effectiveness are unknown.
The new drugs weren’t tested against existing ones, only placebo treatments.
Many study leaders work for or have other financial ties to the drugmakers, and the firms helped analyze results.
Biotech drugs like these have a tendency to be very costly and if they are approved, insurers may set big copays or require patients to try old medicines first, Hershey said. When the medicines did work, the benefit was seen immediately, so there’s less financial risk in trying a couple of doses.
“The patient will know quickly if this is a drug for them and if not, move on to something else,” Hershey said.
Both drugs have been submitted to the U.S. Food and Drug Administration for approval. Eli Lilly and Co. and Alder Biopharmaceuticals also are testing similar drugs.