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| |  FDA Approves Amerge For Migraine Treatment RESEARCH TRIANGLE PARK, NC -- February 11, 1998 -- The United States Food and Drug Administration has granted marketing clearance to Glaxo Wellcome Inc.’s Amerge(TM) (naratriptan hydrochloride) Tablets, a new medication for the acute treatment of migraine. Amerge is a selective 5-HT1 agonist designed specifically to treat migraine attacks. In clinical trials, 60 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 to 81 percent did not have recurrence of headache within 24 hours. Amerge may be an appropriate choice for patients who require more than one dose of their current migraine treatment to maintain relief over a 24-hour period. Glaxo Wellcome currently markets Imitrex(R) (sumatriptan) (sumatriptan succinate) which, when introduced in 1993, was the first medication specifically formulated in 50 years for the acute treatment of migraine. With the introduction of Amerge, Glaxo Wellcome is the only company to market two separate 5-HT1 receptor agonists for the treatment of migraine. 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 (i.e., 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 is indicated for the acute treatment of migraine attacks with or without aura in adults. Amerge is not intended to prevent or reduce the number of migraine attacks nor is it for use in the treatment of cluster headache, or management of basilar or hemiplegic migraine. 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 taken anytime after a migraine starts. Amerge treats the pain and migraine-associated symptoms of nausea and sensitivity to light and sound and is nonsedating 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 ischomia. 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 (including Imitrex) 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. The only reported side effect with a greater than two percent incidence was nausea five percent (placebo four percent). In clinical trials, single doses of 1.0 mg and 2.5 mg Amerge tablet 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.
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