FDA Approves Excedrin as Over-Counter Migraine Remedy

Excedrin became the first over-the-counter migraine medicine Wednesday.

The Food and Drug Administration approved the extra-strength version of Excedrin as powerful enough to treat the pain of mild to moderate migraines, providing a new market for the 20-year-old painkiller.

Manufacturer Bristol-Myers Squibb Co. said it would rename the product Excedrin Migraine within a few weeks, but the cost would not change. The average retail price is about $7.51 for 100 tablets.

The FDA said studies of more than 1,200 patients showed the pills alleviate migraine pain within two to four hours.

About 20 million Americans have migraines, powerful headaches that can last 24 hours and often are accompanied by extreme sensitivity to light and sound. Sufferers typically get prescription drugs for pain and to prevent migraines.

So New York-based Bristol-Myers became the first manufacturer in the fiercely competitive OTC painkiller market to test migraine sufferers--and found extra-strength Excedrin eliminated or greatly reduced pain in 59% of patients within two hours.

After six hours, 79% of patients reported little or no pain.

Each tablet of Excedrin Migraine contains 250 milligrams of acetaminophen, 250 milligrams of aspirin and 65 milligrams of caffeine. Caffeine helps constrict blood vessels that are one source of migraine pain.

The recommended dose is two tablets at the first sign of migraine, repeated every six hours as needed.