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US FDA approves Topamax for migraine prophylaxis

RaritanMonday, August 16, 2004, 08:00 Hrs  [IST]

The US 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, according to a release from Ortho-McNeil. "Many people who suffer from frequent or severe migraines may benefit from preventive therapy," said Dr. Elizabeth Loder, assistant professor of Medicine, Harvard Medical School Headache Management Programme, Spaulding Rehabilitation Hospital, Boston, MA. "For people who experience frequent migraine attacks, Topamax may have a significant impact by helping to reduce how often they occur," she added. 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. 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. Ortho-McNeil Pharmaceutical Inc markets Topamax in the United States. Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) LLC discovered Topamax and conducted the research for the new indication. Both Ortho-McNeil and J&JPRD are wholly owned subsidiaries of Johnson & Johnson.

 
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