WEDNESDAY, July 10, 2019 — A new migraine drug might offer an alternative to people who do not get relief from current medications, a new trial suggests.
The drug, called rimegepant, hasn’t yet been approved by the U.S. Food and Drug Administration. But it belongs to a new class of drugs that has come to the market within the past year — known as CGRP inhibitors.
CGRP is a small protein that is released by the trigeminal nerve during migraine attacks, research shows. It’s believed to play a key role in generating migraine misery.
The three CGRP inhibitors that are already approved by the FDA are all injected drugs that are used regularly to prevent migraine attacks.
But rimegepant is different because it’s an oral medication that treats migraines in progress, explained lead researcher Dr. Richard Lipton.
His team found that among nearly 1,200 migraine patients, the drug outperformed inactive placebo tablets. About 20% of patients who used one dose of rimegepant were pain-free within two hours, compared with 12% of placebo users.
Many other patients, while not pain-free, still got relief, said Lipton, who directs the Montefiore Headache Center at Albert Einstein College of Medicine in New York City.
He is also a paid consultant to rimegepant developer Biohaven Pharmaceuticals, which funded the trial. The findings are published in the July 11 issue of the New England Journal of Medicine.
In the United States alone, over 37 million people suffer from migraines, according to the American Migraine Foundation. The headaches cause severe pain, and often additional symptoms such as sensitivity to light and sound, nausea and visual disturbances.
People with milder migraines may find general pain relievers like naproxen and acetaminophen are enough, according to the foundation. For more severe attacks, there are “migraine-specific” drugs called triptans, which target the brain chemical serotonin.
Triptans have been used for decades, but they don’t help everyone, Lipton said. They also have side effects — like numbness, dizziness and sleepiness — that can make them difficult to take.
Beyond that, triptans constrict the blood vessels, and people at high risk of heart attack or stroke cannot use them.
If approved, Lipton said, rimegepant would offer a new option for those patients.
It would not, however, replace triptans, which are available as low-cost generics. For “very reasonable economic reasons,” Lipton said, they’ll still be the first choice for acute migraine treatment.
Dr. Rachel Colman is an assistant professor of neurology at Mount Sinai’s Icahn School of Medicine in New York City. She wasn’t involved with the study, but reviewed the findings.
Colman agreed that an alternative for treating migraines would be welcome. “There’s a significant need,” she said, “and it would be wonderful to have an additional option that’s a targeted agent.”
The trial included 1,186 adults with migraines that struck two to eight times per month, and were moderate to severe in intensity. About half were randomly assigned to take one dose of rimegepant the next time they had a migraine; the other half were given an identical-looking placebo tablet.
Patients used electronic diaries to rate their symptoms before and after taking the tablet.
Overall, the real drug was more effective in erasing, or at least easing, pain within two hours. Of rimegepant users, 58% said their pain had dissipated, versus 43% of placebo users.
Patients also rated their “most bothersome” symptom — whether it was pain, nausea or sensitivity to light or sound. Just under 38% of rimegepant users were free of their most bothersome symptom within two hours. That compared with 25% of placebo users.
As for safety, Colman said the findings were “reassuring.” After a single dose, just under 2% of rimegepant patients had nausea, and 1.5% developed a urinary tract infection.
There are still questions, though, Colman said. “This trial looked at a single treatment,” she noted. “Does the drug continue to be effective over time? Consistency is important.”
It would also be helpful, Colman said, for studies to focus on patients who’d failed to benefit from triptans, or who cannot take the drugs.
A separate trial in the same journal focused on cluster headaches — a rare disorder that affects about 0.1% of the population. It causes daily bouts of intense pain for a period of weeks to months at a time.
The trial, of 106 patients, tested a new injection drug called galcanezumab, meant to prevent cluster headaches. In the three weeks after one injection, patients suffered about nine fewer headaches per week — versus five fewer among patients given a placebo injection.
The researchers, led by Dr. Peter Goadsby of King’s College London in England, said larger, longer studies are needed to see if the benefit holds up.
For more facts and resources for migraines, visit the American Migraine Foundation.
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Posted: July 2019