New Combo Migraine Drug in the Works
Drug, Called Trexima, Combines 2 Other Migraine Drugs
April 3, 2007 -- A new migraine drug may bring more migraine relief than two
other migraine drugs, a new study shows.
The new drug, called Trexima, is a blend of the migraine drug Imitrex and
the pain reliever naproxen sodium, which is found in drugs including Aleve,
Anaprox, and Naprosyn.
Imitrex and naproxen sodium work differently. Trexima combines those tactics
to ease migraines in two different ways.
Trexima isn't on the market yet, but it has been submitted for FDA
Results of two Trexima trials appear in the April 4 edition of The
Journal of the American Medical Association. Together, the trials included
2,956 adult migraine patients.
The patients were about 40 years old on average. Most were white women.
The researchers included Jan Lewis Brandes, MD, of Tennessee's Nashville
Neuroscience Group. They split the patients into four groups.
The first group got Trexima pills. The second group got Imitrex. A third
group got naproxen sodium. The fourth group got an inactive pill (placebo).
Patients were told to take their assigned pill when migraine symptoms became
moderate or severe during the following six weeks. They noted migraine symptoms
and migraine pain in the 24 hours after taking their pill.
Trexima "resulted in superior clinical benefits" when compared with
Imitrex, naproxen sodium, or placebo, note Brandes and colleagues.
In both trials, more patients taking Trexima reported migraine relief two
hours after taking their assigned pill and sustained headache relief more than
24 hours after taking the pill.
Fewer patients taking Trexima reported sensitivity to light and sound (two
common migraine symptoms) two hours after taking their assigned pill, the study
Side effects were relatively rare, but they were twice as common in the
Trexima group as in the placebo group.
Trexima had an "acceptable and well-tolerated" side effect profile,
write the researchers. A similar proportion of patients taking Trexima and
Imitrex reported side effects.
The researchers didn't test Imitrex and naproxen sodium taken at the same
time in separate pills. They write that the combination pill has "obvious
advantages" for patients who have trouble taking two pills.
The study was funded by GlaxoSmithKline, which makes Imitrex, and Pozen
Inc., which makes Trexima. GlaxoSmithKline is a WebMD sponsor.
A Pozen news release says the FDA may decide on Trexima by Aug. 1, 2007. If
so, the drug "could be available to patients in the second half of
2007," states Pozen.
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