Three US Food and Drug Administration advisory committees haverecommended by a unanimous vote that Bristol-Myers Squibb's Excedrin Extra Strength (acetaminophen) is an effective over-the-counter analgesic for the relief of migraine.
If the FDA follows the recommendation, the 20-year-old Excedrin product will become the first and only approved OTC medication for migraine with a sound clinical database.
B-MS conducted three clinical trials including a total of 1,250 migraine sufferers in its dossier for the new indication. The results of these studies suggest that Excedrin, when given for the acute treatment of a migraine attack, reduced pain to "mild" or "none" in 59% of patients at two hours, and 79% at six hours.
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