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U.S. FDA Approves Topamax for Migraine Prophylaxis

RARITAN, NJ -- August 12, 2004 -- There is new hope for the millions of Americans who have frequent or severe migraines. The U.S. Food and Drug Administration (FDA) has approved Topamax® (topiramate) Tablets and Topamax (topiramate capsules) Sprinkle Capsules for the prophylaxis (prevention) of migraine headaches in adults. In clinical studies with Topamax, many people with migraines experienced significantly fewer attacks, enabling them to help manage their condition.

Clinical trials found that patients receiving the recommended daily dose of Topamax experienced a significant reduction in monthly migraine attacks, compared with placebo.

Migraines are a chronic, debilitating condition characterized by sharp throbbing pain on one side of the head, nausea or vomiting, visual disturbances, and/or sensitivity to noise and light. Approximately 14 million Americans suffer from frequent or severe migraines. Many prescription migraine medicines currently available are taken to treat migraines at the start of an attack. For many people with frequent or severe migraines, this approach may not be enough. These patients may be candidates for treatment that may reduce the frequency of their migraine attacks.

"Many people who suffer from frequent or severe migraines may benefit from preventive therapy," said Elizabeth Loder, MD, Assistant Professor of Medicine, Harvard Medical School Headache Management Program, Spaulding Rehabilitation Hospital, Boston, Massachusetts. "For people who experience frequent migraine attacks, Topamax may have a significant impact by helping to reduce how often they occur."

According to the National Headache Foundation (NHF), a leading advocacy organization, people with migraines are often forced to cope with their attacks. While some retreat and wait out an attack, many attempt to endure them, struggling through even the simplest tasks such as completing household chores.

"I work and have a family to take care of so having fewer migraines is very important to me," explained Sandra Bryan, a Topamax clinical trial patient. "Taking Topamax for my migraines reduced the number of migraines I had each month, allowing more time for the things I wanted to do."

People with migraines should talk to their doctors about the treatment options that are right for them. Factors to discuss include the frequency and severity of their migraines; medications they are currently using; how often they are using their migraine medications; and how well their current migraine medications are working.

"Many people who may be candidates for migraine prevention are not offered this as an option," said Dr. Loder. "Physicians are more likely to recommend appropriate treatment when patients fully discuss their condition."

Topamax has been approved for migraine prophylaxis in 22 countries worldwide. Topamax is indicated for the prophylaxis of migraine headaches in adults. The usefulness of Topamax in the acute treatment of migraine headaches has not been studied. Like most medicines, Topamax may cause side effects. The most common side effect is tingling in the extremities. Others include fatigue, loss of appetite, nausea, taste alteration, diarrhea, cognitive side effects and weight loss. Serious, as well as minor, side effects have been reported with Topamax. Please see full U.S. Prescribing Information.


SOURCE: Ortho-McNeil Pharmaceutical, Inc.

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