FDA CLEARS NEW DRUG FOR MIGRAINE

WASHINGTON - Pharmaceutical giant Glaxo-Wellcome said Wednesday it had won
marketing clearance from the Food and Drug Administration (FDA) for Amerge,
a new, longer-acting migraine medicine.

Amerge, known generically as naratriptan, is one of a newer class of
migraine drugs called triptans that act on a brain chemical known as
serotonin.

Scientists are not sure just how they work, but they can reduce the pain of
migraines and symptoms such as the auras that many sufferers see around
objects.

In clinical trials, between 60 and 66 percent of volunteers with moderate
to severe headache said Amerge helped their pain within four hours, and the
pain stayed away for a day in between 72 and 81 percent of the volunteers.

More than 26 million people in the U.S. suffer from migraine. It affects
585 million people worldwide or one in 10 of the world's population.

Besides causing severe headache, migraines can also cause nausea, vomiting, and
sensitivity to light, sound and smell. Attacks can last from four to 72 hours.

Amerge is meant to have longer-lasting effects than Imitrex (sumatriptan),
Glaxo's other triptan.

``While Imitrex offers fast relief and efficacy, there are many migraine
sufferers for whom the long duration of their headaches is of greatest
concern,'' Dr Ninan Mathew of the Houston Headache Clinic in Texas, who
helped in trials of the drug, said in a statement.

``The introduction of Amerge provides another option for these sufferers to
be treated for this debilitating disease. This medication is effective,
long-lasting and well-tolerated in most patients.''

People who have symptoms or signs of ischemic heart disease, including
chest pain or heart attack, stroke, high blood pressure or other vascular
problems, should not take Amerge or any other triptan because it can
constrict the arteries leading from the heart.

It also should not be taken with other migraine medications.

Many companies are racing to get new migraine drugs onto the market.

In December the FDA approved a new nose-spray formulation of Novartis
Pharmaceuticals' Migranal, just after Glaxo won approval for a nose-spray
formulation of Imitrex.

There are also over-the-counter remedies. Last month the FDA said
Bristol-Myers Squibb could package its Excedrin Extra Strength as a
migraine medicine.

Analysts have estimated that Imitrex, sold as Imigran in Europe, holds as
much as 70 percent of the $1.1 billion global migraine market. Naratriptan
is already sold as Naramig in Europe.