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| |  Zomig May Provide Faster Acute Migraine Response Rates Than Sumatriptan SAN FRANCISCO, CA -- June 29, 1998 -- Data presented at the American Association for the Study of Headache meeting show that there was a statistically significant difference between treatment groups, in terms of pain relief over 24 hours, favouring Zeneca Pharmaceuticals’ Zomig(TM) (zolmitriptan) 2.5 mg Tablets versus both sumatriptan 25.0 mg and 50.0 mg. Sumatriptan is the most-commonly prescribed triptan for migraine headache currently on the market. One of the most important issues for migraine sufferers has been the inability of medications to provide consistent, rapid and effective relief they can rely on at the time of the attack and beyond. "The significant difference is higher headache response rates from zolmitriptan and less use of escape medication," said Dr. R. Michael Gallagher of the University of Medicine and Dentistry of New Jersey, School of Osteopathic Medicine, and a lead investigator of the trial. The percentage of patients responding at two hours postdose significantly favoured Zomig 2.5 mg versus sumatriptan 25.0 mg and 50 mg (67.1% versus 59.6% and 63.8%, respectively.) In the randomised, double-blind, active-controlled study, the two-hour headache response statistically favoured patients receiving Zomig 2.5 mg, and the statistical difference over sumatriptan 25.0 mg and 50.0 mg was maintained at four hours. The multicentre trial, known as ZOMCO, involved 1,455 patients from 61 research centres. A total of 6,187 migraine attacks were treated with Zomig and sumatriptan. "The results demonstrate that Zomig is a well-tolerated, safe, and fast- acting treatment option for acute migraine attacks," Dr. Gallagher said. Another new study presented at AASH showed that Zomig 2.5 mg and 5.0 mg have statistically significant higher headache response rates than placebo at 45 minutes and beyond. Zomig 2.5- and 5.0-mg tablets were cleared for marketing by the U.S. Food and Drug Administration in November 1997 for treatment of acute migraine with or without aura in adults. Zomig was made available by prescription in pharmacies nation-wide in January. Zomig is contraindicated for patients with uncontrolled hypertension, ischemic heart disease, or other significant underlying heart disease. Patients who have risk factors for heart disease should be fully evaluated by their physician prior to initiation of therapy with Zomig. In addition, Zomig should not be administered to patients who are hypersensitive to zolmitriptan or any of the inactive ingredients of the drug. Zomig should only be used where a clear diagnosis of migraine has been established. As with other serotonin agonists, sensations of tightness, pain, pressure and heaviness have been reported after treatment with Zomig tablets in different regions of the body, including the chest. In a safety database of more than 4,000 patients, Zomig was well tolerated. Adverse events reported by patients were mostly mild or of moderate intensity and the most common included asthenia (lack of energy), nausea, dizziness, somnolence (drowsiness) and paresthesia (feelings such as tingling, numbness or itching). More information on: Zomig, Zeneca Pharmaceuticals
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