To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Clears Excedrin Migraine For Migraine Headache Pain URL: http://www.pslgroup.com/dg/50C7E.htm Doctor's Guide January 15, 1998
NEW YORK, NY -- January 15, 1998 -- The United States Food and Drug Administration has granted marketing clearance to Bristol-Myers Squibb's Excedrin(R) Migraine for the relief of migraine headache pain, a condition suffered by approximately 25 million Americans. Excedrin Migraine will be the first and only migraine medication available to consumers without a prescription. "This is important news for the millions of migraine sufferers who self-medicate with over-the-counter products in a trial-and-error fashion, not knowing which medicines to use, or in what dosages," said Richard Lipton, MD, co-director of the Headache Unit at Montefiore Medical Center. Dr. Lipton is a professor of neurology at Albert Einstein College of Medicine and was a lead investigator of the Excedrin Migraine clinical trials. "Now, people with migraine will have easy access to a clearly labelled, non-prescription treatment that has been clinically proven to relieve migraine headache pain," he said. Excedrin Migraine, cleared for the treatment of mild to moderate migraine pain, contains the same safe and effective formula as Excedrin(R) Extra Strength, which has been on the market for more than 20 years. At the request of the FDA, Excedrin Migraine will have its own trademark and distinctive packaging in order to provide important information about appropriate use and when to consult a doctor. It will be available in stores nationwide in early 1998 at the same suggested retail price as Excedrin Extra Strength. The FDA decision was based on compelling clinical data from three double-blind, randomised, placebo-controlled clinical trials of 1,250 migraine sufferers that found Excedrin Migraine to be significantly effective in relieving migraine headache pain. Patients in the study suffered from migraine attacks that typically lasted 24 hours when untreated. Excedrin Migraine demonstrated rapid relief in some patients as early as one-half hour after treatment. Within two hours, almost two-thirds (59 percent) of patients with moderate or severe pain reported mild or no pain after treatment with Excedrin Migraine. At six hours, the results were even more dramatic, with 79 percent of Excedrin-treated patients reporting little or no pain. At the joint FDA Advisory Committees meeting held on July 15th, numerous national consumer and medical organisations voiced strong support for the availability of a clinically-proven, clearly-labelled, non-prescription migraine medication. Approximately 75 percent of migraine sufferers are women and people in their thirties experience more migraines than any other age group. Migraines are usually characterised by throbbing or pulsing pain on one side of the head, nausea and/or extreme sensitivity to light and sound. People suffering from more severe migraine may first experience migraine aura, such as a visual display of flashing lights or zig zag lines, or a greying out of vision. "Patients with severely disabling symptoms should see a physician about their migraine headaches," said Dr. Lipton. The Excedrin Migraine label clearly instructs patients to contact a doctor if they experience any potentially serious symptoms along with headache, including pain so severe as to require bed rest, stiff neck or vomiting. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.