(HealthDay)—Migraine sufferers who cannot get relief from
existing medications may soon have a novel treatment option, a new trial
suggests. The study, of nearly 1,700 patients, found that a pill called
ubrogepant worked better than a placebo pill at halting migraines in progress.
The drug has not yet been approved by the U.S. Food and Drug
Administration. But it belongs to a new class of medications called CGRP
inhibitors that has come to the market in the past year.
CGRP is a small protein released by the trigeminal nerve
during migraine attacks. It's believed to play a key role in generating
migraine misery, explained lead researcher Dr. Richard Lipton, who directs the
Montefiore Headache Center at Albert Einstein Medical College in New York City.
The three approved CGRP inhibitors are all injection drugs
that are used regularly, to prevent migraine attacks.
Ubrogepant is different because it's a tablet that treats
migraines in progress. Another oral "gepant," called rimegepant, is
also in the pipeline. Data on both drugs have been submitted to the FDA for
approval, according to the companies developing them.
In the new study, ubrogepant worked better than a placebo at
easing pain and other migraine symptoms, such as nausea and sensitivity to
light or sound.
Of patients who used the real drug to treat a migraine
attack, 22% of those on a higher dose were pain-free within two hours. That
compared with 14% of the placebo group. Similarly, 39% of ubrogepant users were
free of their "most bothersome" symptom within two hours, versus 27%
of placebo users.
The study, funded by drug's maker, Allergan, is published in
the Nov. 19 issue of the Journal of the American Medical Association.
According to Lipton, the new gepants could make a "big
difference" for certain migraine patients.
They include people who do not get relief from current acute
treatments, and those who cannot take the medications because of side effects
or safety concerns, Lipton said.
Right now, medications called triptans are the standard
treatment for more severe migraine attacks. The drugs, which came out in the
1990s, stop migraines by stimulating receptors for the brain chemical
serotonin, which reduces inflammation and constricts blood vessels.
But not everybody responds to the medications. And because
of the blood vessel constriction, people at high risk of heart attack or stroke
cannot take them.
Triptans also have side effects—like numbness, dizziness and
sleepiness—that can make them difficult to take.
Gepants work through a "novel mechanism," Lipton
said, which means they might help some patients who do not respond to triptans.
And they do not constrict blood vessels.
Lipton has financial ties to both Allergan and Biohaven
Pharmaceuticals, maker of rimegepant.
It will be "exciting" to have new options for
patients who cannot take triptans, said a neurologist who was not involved in
the study.
"There haven't been any new acute treatments in a long
time," said Dr. Rachel Colman, of Mount Sinai's Icahn School of Medicine
in New York City.
Questions do remain, Colman pointed out. The latest trial
tested the effects of only a single treatment, and it's not clear how
consistent patients' responses will be over time, she said.
Long-term safety and side effects are also unknowns—though,
Colman said, "so far, the tolerability data looks good."
Nausea was the most commonly reported side effect, affecting
2% of ubrogepant patients within two days of taking the drug.
In the United States alone, more than 37 million people
suffer from migraines, according to the American Migraine Foundation. People
with milder migraines may find relief with general pain relievers like naproxen
and acetaminophen.
But for some migraine sufferers, Colman noted, "there's
a significant need" for new tactics.
According to Lipton, Allergan said it expects FDA approval as early as next month.
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