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| |  AAN MEETING: Studies Show Maxalt Relieves Migraine Faster Than Oral Sumatriptan MINNEAPOLIS, MN -- April 30, 1998 -- Merck & Co., Inc.’s investigational medicine Maxalt(R) (rizatriptan benzoate), eliminated migraine pain significantly faster than oral sumatriptan, the leading oral migraine treatment, according to a new study presented today at the 50th annual meeting of the American Academy of Neurology. Other data from this study and another study presented here showed that at two hours, Maxalt relieved migraine-associated symptoms such as nausea, vomiting and sensitivity to light and noise for more patients than oral sumatriptan. Jerome Goldstein, M.D., director of the San Francisco Headache Clinic, presented data from a placebo-controlled head-to-head study of 1,170 patients that compared Maxalt 10 mg and 5 mg to oral sumatriptan 50 mg and 25 mg, respectively. Patients reported their degree of migraine pain, nausea, photophobia (sensitivity to light), phonophobia (sensitivity to sound) and functional disability at half-hour intervals starting at the time of administration through two hours, as defined by International Headache Society guidelines. The primary endpoint was a comparison of the percent of patients who first reported pain relief within two hours after dosing, which is referred to as time-to-relief. In this study, Maxalt 10 mg relieved migraine pain faster than sumatriptan 50 mg, the primary hypothesis of the study and Maxalt 5 mg relieved migraine pain faster than sumatriptan 25 mg. Both Maxalt 10 mg and 5 mg relieved migraine pain within 30 minutes of dosing for some patients. This was statistically significant compared to placebo. In addition, Maxalt 5 mg was statistically superior to sumatriptan 25 mg at two hours in: relieving pain (reduction from severe to moderate to mild or no headache); providing complete relief of pain (reduction from severe or moderate to no headache); and relieving nausea and vomiting. Neither dose of sumatriptan was statistically superior to the comparison dose of Maxalt on any measure at the two-hour time point. In this study and all clinical trials of Maxalt, including study extensions of up to one year, the most common adverse events were drowsiness, dizziness and fatigue. These events were generally mild and transient in nature. Patients taking placebo also experienced many of these events, although at lower rates. A placebo-controlled head-to-head study of 1,095 patients, compared Maxalt 10 mg and 5 mg to sumatriptan 100 mg using the same measures as the previous. The primary results from this study showed that Maxalt 10 mg tablets had a statistically significant faster onset of headache relief and relieved nausea for more patients than sumatriptan 100 mg and that Maxalt 10 mg relieved migraine pain within 30 minutes for some patients. A new post-hoc analysis of the study showed that in patients with nausea and other migraine-associated symptoms such as sensitivity to light and noise at baseline, Maxalt 10 mg and 5 mg were statistically superior to sumatriptan 100 mg in providing symptom relief. Significantly more patients who had these symptoms at baseline experienced relief of these migraine symptoms with Maxalt 10 mg through two hours than with sumatriptan 100 mg, and more patients experienced relief of nausea through two hours with Maxalt 5 mg than with sumatriptan 100 mg. "Patients who suffer from migraine want their pain and other symptoms, especially nausea, alleviated quickly and completely so they can get on with their lives," Dr. Goldstein said. "In the studies presented here, the investigational medicine Maxalt relieved migraine pain faster and eliminated other migraine symptoms for more patients than oral sumatriptan. "Based on these findings, Maxalt has the potential to become a leader of the triptan class of migraine therapies." In placebo-controlled studies of Maxalt, 93 percent of patients achieved pain relief at two hours with Maxalt on their first or second attack. Data from long-term extension studies showed that for the typical (median) patient, Maxalt 10 mg relieved migraine pain for 90 percent of migraine attacks by two hours. More information on: Merck & Co., Inc..
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