Fate of New Migraine Drug Is Uncertain
Researchers Say Telcagepant May Help Treat Migraines, but Safety Issues Remain
April 21, 2010 -- An experimental migraine drug could help many patients who
can't take or don't respond to current treatments, but questions remain about
Studies suggest that the drug telcagepant works in many people whose
headache pain is not relieved with triptans, which are considered the most
effective currently available drugs for treating migraines.
As many as a third of migraine sufferers fall into this category, according
to one research analysis.
Since triptans cause the blood vessels to constrict, they may not be
considered appropriate for use in people with heart disease or angina, history
of stroke, uncontrolled high blood pressure, or pregnant women.
Telcagepant is a new type of migraine drug that blocks the
calcitonin-gene-related peptide (CGRP) receptor.
In a review of investigational migraine treatments published today in The
Lancet, migraine researchers Lars Edvinsson, MD, and Mattias Linde, MD,
write that CGRP-targeting drugs may prove to be an important advance in
But it is not clear if drugmaker Merck & Co., which developed
telcagepant, will pursue regulatory approval for the drug due to concerns about
its potential toxic effect on the liver.
Last spring, a phase II trial of telcagepant for the prevention of migraines
was stopped early after several patients developed elevated liver enzymes
indicative of possible liver damage.
When the treatment was stopped, liver enzyme levels returned to normal.
After meeting with regulatory authorities, Merck agreed to conduct an
additional safety study of the drug.
Until that trial is completed, the company will not decide whether to seek
approval for telcagepant as a migraine treatment, Merck spokeswoman Pam Eisele
Edvinsson tells WebMD that with the exception of the unresolved questions
about liver safety, the CGRP receptor blockers seem to have fewer troublesome
side effects than triptans.
Patients who take triptans often complain of nausea, dizziness, abnormal
skin sensations like numbness or tingling, or throat or chest tightness.
Some 28 million Americans have some experience with migraines, including 25%
of women and 8% of men, according to the National Headache Foundation.
In some people, symptoms are limited to severe headache. In others,
headaches are accompanied by nausea and vomiting, sensitivity to light and
noise or visual displays preceding or during attacks known as aura.
Migraine specialist Stephen Silberstein, MD, tells WebMD that new drug
treatments for migraine are definitely needed. But he adds that it is unlikely
that a single drug or drug combination will be appropriate for all migraine
Silberstein is a professor of neurology and directs the Jefferson Headache
Center at Philadelphia's Thomas Jefferson University. He is also a past
president of the National Headache Society.
"There are three important things to understand about migraine treatment,"
he says. "Drugs don't always work, when they work they don't work for
everybody, and they usually have side effects."
He says promising nondrug treatments, such as a handheld device that zaps
migraine pain, may be as important as new drugs.
Silberstein took part in a recent study of the portable device, known as
single-pulse transcranial magnetic stimulation (sTMS).
Edvinsson has served as a paid consultant for Merck and several other drug