Agency Approves New Injectable Drug for Migraines

The Food and Drug Administration on Tuesday approved an injectable drug to relieve pain from migraine headaches, a condition that affects millions of people.

In clinical trials the drug, sumatriptan, relieved pain in 80% of the patients within two hours of injection, the FDA said in a statement.

“Sumatriptan should improve the quality of life for many of the millions of people who suffer from these debilitating headaches,” FDA Commissioner David Kessler said.

Migraines are intensely painful, often on one side of the head, and recur periodically.

The agency said the drug is not a cure for migraines and warned that it should not be used by people with heart disease because it can constrict the coronary arteries.

The FDA also said pregnant women ought to be cautious about using the drug because animal studies on its safety have been inconclusive.

Sumatriptan caused fetal deaths in rabbits but not in rats.

The manufacturer, Glaxo Inc., said it will collect information on what happens to women who get pregnant while on the drug.

Although there is another treatment for migraines, Cafergot, not everybody can use it, said Carol Scheman, deputy FDA commissioner for external affairs.

Sumatriptan also appears to take effect more quickly than Cafergot, she said in an interview.

The clinical trials found that some patients felt the effects in 10 to 30 minutes, a total of 75% reported relief within an hour and the percentage who reported relief reached 80% within two hours, the FDA said.

The drug, which will be marketed under the brand name Imitrex, will be available in an auto-injector, a device that will let patients give themselves a 6-milligram injection.

The FDA recommended that patients receive the initial dose from a physician.