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| |  Maxalt Relieves Migraine Pain Faster Than Oral Sumatriptan AMSTERDAM, June 12, 1997 -- The new investigational oral migraine treatment, Maxalt(TM) 10 mg (rizatriptan benzoate), provides significantly faster relief of migraine pain, and a better effect on nausea and functional disability than the current treatment standard, oral sumatriptan 100 mg, according to results of a comparative study presented for the first time yesterday at the 8th Congress of the International Headache Society. The study also showed that Maxalt 10 mg helped more patients become pain free within two hours than sumatriptan 100 mg. "Based on these findings, Maxalt may be a promising option for physicians to help relieve their patients' migraines," said Stephen D. Silberstein, M.D., co-director of the Comprehensive Headache Center in Philadelphia and a clinical investigator for Maxalt. "Rizatriptan may help millions of people worldwide who suffer from the debilitating effects of migraine." "Speed of pain relief is a critical need for migraine sufferers. Rizatriptan worked as fast as 30 minutes for some patients to meet that need," said Dr. Hester Visser, of the Merck Neuroscience Research Center in Harlow, Essex, U.K. "Moreover, this study shows that Maxalt 10 mg provided quicker relief of pain, nausea and disability than the current `gold standard' of migraine therapy." In the international trial, which involved 1,099 patients, Maxalt 10 mg showed statistically significant improvements over sumatriptan 100 mg in the number of patients who: -- experienced headache relief at 1 hour An analysis of the first time a patient reports either no headache or a mild headache showed that Maxalt 10 mg had a significantly earlier onset of headache relief than sumatriptan within two hours of treatment. At two hours, 67 percent of patients on Maxalt 10 mg reported relief from their migraine, while patients receiving sumatriptan achieved rates of 62 percent at two hours. In other studies presented at this meeting, Maxalt 10 mg provided migraine relief for 71 to 80 percent of patients at two hours. In this and other studies, Maxalt 10 mg provided relief of migraine pain as fast as 30 minutes. Percentages of patients reporting relief at 30 minutes ranged from 13 to 28 percent. Data from long-term extensions showed that for the typical (median) patient, Maxalt 10 mg relieved 90 percent of migraine attacks by two hours. Maxalt Improved Quality of Life "Most importantly, these clinical outcomes translated into an important and often overlooked measure: the impact on migraine sufferers' quality of life,"said Dr. Silberstein, who helped develop the quality of life evaluation tool. In a study of more than 260 people, those taking Maxalt 10 mg reported significant improvement over their usual or standard migraine therapy. Quality of life measures included migraine symptoms such as feelings/concerns, work functioning, social functioning, energy/vitality and mental health. Migraines are not just ordinary headaches, but are characterized by unpredictable attacks of intense, usually one-sided, throbbing headaches with other symptoms An overwhelming majority of those with migraine also experience nausea, and many experience aggravated sensitivity to light and noise (called photophobia and phonophobia) and vomiting. Without treatment, symptoms of migraine can last between four hours and a day, sometimes longer, and can severely limit the sufferers' ability to function. About Maxalt "Maxalt represents a new generation of migraine therapy and may provide a new and effective option for migraine sufferers," said Dr. Visser. Maxalt, a highly selective 5-HT1B/1D agonist, was discovered at Merck's Neuroscience Research Center in Terlings Park, U.K. In clinical studies, it worked to relieve migraines by constricting swollen blood vessels around the brain, preventing the release of neuropeptides that cause further dilation of those vessels, and blocking pain signals from sensory nerves to the brain. Merck has recently completed its Phase III studies for Maxalt. Approximately 3,000 patients worldwide took Maxalt in Phase II and III studies. Two dosages, 5 mg and 10 mg, and two formulations are under development: a tablet and a wafer that disintegrates in the mouth. Ten milligrams will be recommended as the primary dose. Merck plans to file for regulatory approvals in many countries this year; a New Drug Application will be submitted to the U.S. Food and Drug Administration in the first half of this year. Maxalt was well tolerated in this study and in all clinical trials, including study extensions of up to one year. The most common adverse events (drowsiness, dizziness, and fatigue) were generally mild and transient in nature. Patients taking placebo also experienced many of these events, although at lower rates. Merck & Co., Inc. is a research-driven pharmaceutical products and services company. Merck discovers, develops and markets a broad range of innovative products to improve human health.
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