To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Amerge Tablets Now Available In U.S. For Migraine Attacks URL: http://www.pslgroup.com/dg/64336.htm Doctor's Guide March 24, 1998
RESEARCH TRIANGLE PARK, NC -- March 24, 1998 -- Glaxo Wellcome Inc.'s Amerge(TM) (naratriptan hydrochloride) Tablets, a therapy for the acute treatment of migraine, is now available in the United States by prescription. Amerge is a selective 5-HT1 agonist designed specifically to treat migraine attacks. In clinical trials, 60 percent to 66 percent of patients with moderate to severe headache responded to Amerge 2.5 mg within four hours. Of the patients who had relief with the initial dose, 72 percent to 81 percent did not have recurrence of headache within 24 hours. Amerge offers a new choice for patients who have migraines of long duration, experience recurrence or have tolerability issues with other migraine therapies. Migraine is an often debilitating, biological disease characterised by severe pain, usually on one side of the head and often accompanied by one or more of the following symptoms: nausea, vomiting and sensitivity to light, sound and smell. Attacks occur periodically and can last from four to 72 hours. In a well-controlled clinical trial of 682 migraine patients, two-thirds (66 percent) of patients experienced headache relief (for example, a reduction from severe or moderate pain to mild or no pain at all) within four hours of receiving 2.5 mg of Amerge, compared to less than one-third (27 percent) of patients who received placebo. Fifty-three percent of patients still had relief 24 hours after taking the medication as compared to 27 percent for the placebo group. Amerge has been studied in clinical trials with nearly 3,500 patients world-wide, involving more than 20,000 migraine attacks. Amerge has a demonstrated clinical efficacy profile and may be given anytime after a headache starts. Amerge treats the pain and migraine-associated symptoms of nausea and sensitivity to light and sound and is non-sedating and non-narcotic. The drug is contraindicated in patients with history, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive Amerge Tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina such as the Prinzmetal's variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes and peripheral vascular disease include but are not limited to strokes, transient ischemic attacks or ischemic bowel disease. Patients with risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or are postmenopausal or a male over 40) should be evaluated by a physician to determine if Amerge is appropriate therapy. Amerge is contraindicated in patients with severe renal or hepatic impairment and should not be given to patients with uncontrolled hypertension because it may increase blood pressure. Amerge Tablets should not be used within 24 hours of administration of another 5HT agonist or any ergotamine-containing or ergot-type medicines, like dihydroergotamine or methysergide. Amerge should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Overall, incidence of adverse events for both Amerge 2.5 mg (30 percent) and placebo (29 percent) was comparable. Side effects associated with Amerge in clinical trials were generally mild and transient. Amerge and should only used where a clear diagnosis of migraine has been established. With Amerge Tablets, the incidence of chest and cardiovascular-related adverse events was low (less than or equal to 1 percent). The drug has been cleared for marketing in 14 countries, including the U.K., Germany and Sweden. In clinical trials, single doses of 1.0 mg and 2.5 mg Amerge Tablets were effective. A greater proportion of patients achieved headache response with the 2.5 mg dose. The maximum dose recommended is 5 mg in a 24-hour period. More information on: Glaxo Wellcome Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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