FDA Panel OKs Drug to Treat Migraines : Health: Committee will urge approval of sumatriptan. Studies are said to show it is safe and effective in eliminating severe pain of headaches.

A Food and Drug Administration advisory committee voted unanimously Friday to recommend approval of a new drug that can eliminate the severe pain of migraine headaches for many sufferers.

Panel members agreed that the manufacturer has sufficient data from human studies to show that the drug, sumatriptan, is safe and effective for acute migraine attacks, said Paul Leber, director of the FDA’s division of neuropharmacological drug products.

“We will consider seriously the recommendation,” Leber said. The FDA usually follows the recommendations of its advisory panels, which are composed of outside scientific experts.

About 8 million Americans suffer from intense, disabling headaches known as migraines.

The drug acts differently from other migraine treatments that have been approved in that it stimulates receptors in the walls of blood vessels only in the head and neck, causing them to constrict. It is dilation of these blood vessels that is believed to cause the pain of migraines.

Officials of Glaxo Inc. presented the results of studies that showed that about 80% of the nearly 2,000 patients who took the drug were helped by it. The drug was compared with placebos in the studies.

The studies showed that sumatriptan, also known by its trade name Imigran, had fewer side effects than other drugs that are used to treat migraines, company spokesmen said.

The most common side effect of sumatriptan was pain and redness at the injection site, which usually lasted less than an hour, said Tony Fox, director of cardiovascular clinical research at Glaxo Inc. Research Institute in Research Triangle Park, N. C.

Less common side effects included achiness, tingling and flushing, he said.

A number of drugs are available to treat migraines, but many cause gastric distress, nausea, vomiting and other side effects.

Although studies have not shown the drug to cause coronary problems, this remains a concern because the drug acts specifically to constrict blood vessels, Leber said.

The drug is delivered by injection, but the company is developing an oral form, Fox said. Patients in the trials either used an auto-injection device or visited a hospital or clinic where a physician administered the injection, Fox said.

The drug was administered as much as 24 hours after a migraine attack and still relieved the pain, he said.

In one study, about 90% of patients getting sumatriptan found their headaches were mild or gone completely after about two hours, compared to about one-third of the patients who received placebo shots.

However, the studies do not show the drug to be useful in preventing the onset of migraine attacks, Leber said.