To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Extends Excedrin Migraine Indication To Full Migraine Syndrome URL: http://www.pslgroup.com/dg/139082.htm Doctor's Guide October 13, 1999
NEW YORK, N.Y. -- October 13 -- The Food and Drug Administration has expanded the Excedrin® Migraine indication from just "the treatment of mild to moderate migraine pain" to encompass even the severe pain and associated symptoms of the full migraine syndrome, including nausea, sensitivity to light, sensitivity to sound, and difficulty performing usual activities.
In January 1998, Excedrin Migraine became the first over-the-counter medication approved for mild to moderate migraine pain; now, an expanded review of the clinical data has led to this broader indication.
"This approval confirms that the non-prescription medication Excedrin Migraine safely and effectively treats the same symptoms as leading prescription migraine drugs," said principal investigator Richard Lipton, MD, of the Headache Unit at Montefiore Medical Center, Bronx, New York and Innovative Medical Research.
By definition, all of the estimated 25 million migraine sufferers in the United States experience one or more of these associated symptoms along with head pain.
Proven Effective in Clinical Trials
The FDA decision was based on compelling clinical data from three double-blind, randomized, placebo-controlled clinical trials of 1,250 migraine sufferers. In addition to migraine pain, which was significantly reduced by Excedrin Migraine, the aspirin-acetaminophen-caffeine combination also relieved the associated symptoms of migraine. In clinical trials, approximately twice as many Excedrin Migraine-treated patients reported no photophobia (sensitivity to light) or phonophobia (sensitivity to sound) as placebo-treated patients. Additionally, 69 percent of Excedrin-treated patients reported little or no functional disability (difficulty performing usual activities), compared with 41 percent of placebo-treated patients.
"While physicians have known for years that the combination of aspirin, acetaminophen and caffeine-the active ingredients in Excedrin Migraine-relieves migraine headache pain, its proven effectiveness in treating the condition's other debilitating symptoms is a very positive finding," said Dr. Lipton.
A Closer Look at Migraine
All of the nation's 25 million migraine sufferers experience at least one of the associated symptoms along with their pain; many experience several of them concurrently. More than 18 million experience nausea along with their headache pain, more than 20 million experience sensitivity to light or sound, and more than three-quarters of migraine sufferers are debilitated to the point that they have difficulty performing usual activities. In addition, many suffering from migraine may first experience migraine "aura," such as a visual display of flashing lights or zig-zag lines, or a graying out of vision.
"Of course, anyone with extremely disabling symptoms should contact a physician about their migraine headaches," said Dr. Lipton. "But the majority of migraine sufferers will find relief with Excedrin Migraine."
Excedrin Migraine, the number one doctor recommended non-prescription migraine treatment, is made by Bristol-Myers Squibb Company.
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