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| |  Amerge (naratriptan hydrochloride) helps treat perimenstrual migraines RESEARCH TRIANGLE PARK, NC -- May 4, 2999 -- Amerge(R) (naratriptan hydrocloride) Tablets have been studied for preventing or reducing the number of menstrually-associated migraines, according to a clinical study presented this week at the annual meeting of the American Academy of Neurology. Further research needs to be done to determine the efficacy and safety of Amerge for this use. In the study, more patients treated prophylactically with Amerge 1 mg Tablets reported no migraines in treated perimenstrual periods than patients treated with placebo (23 percent vs. 8 percent). Sixty-one percent (61 percent) of women treated with Amerge 1mg reported no headache in at least half of their treated perimenstrual periods compared to 38 percent of the placebo group. The total number of treated perimenstrual periods without an associated migraine was higher in the group taking Amerge 1 mg versus placebo (50 percent vs 25 percent). For all menstrually-associated migraines (MAMs) that broke through the prophylactic therapy, the total hours of migraine pain/symptoms per attack were significantly reduced for patients treated with Amerge 1 mg Tablets (13.8 hours) compared with placebo (20.4 hours). The results with Amerge 2.5 mg Tablets (19.2 hours) were not statistically different from placebo. The effect of Amerge 2.5 mg Tablets in preventing or reducing menstrually-associated migraine was not statistically different from placebo. In addition, the number of MAM headaches with respect to migraine type and severity were similar across all treatment groups. Menstrually-associated migraine was defined in this study as any migraine headache occurring during the perimenstrual period, defined as beginning two days before the onset of menses and ending four days after the onset of menstrual flow (six days total), where Day 1 was defined as the onset of menses. Patients in the study were required to have regular menstrual periods and be able to predict the onset of menstrual flow, within one to two days. The women in the study were at least 18 years old with at least a six-month history of menstrually-associated migraine. They took either 1 mg or 2.5 mg Amerge Tablets or a placebo tablet twice a day for five days - starting two days before the expected onset of a menstrually-associated migraine. The study was double-blinded, meaning neither the physician nor patient knew which treatment the patient was taking until the study was completed and the data were analyzed. The study was conducted at 18 sites in the U.S., where a total of 206 women participated. Of that number, 171 (83 percent) completed the course of treatment throughout four menstrual cycles. During the study, patients also were required to keep a diary in which they recorded details of every migraine attack during the study period, including severity and number of hours missed from work/activity due to migraine symptoms. They rated their effectiveness at performing these activities as a measure of productivity loss. "An effective prophylactic therapy that reduces the incidence or length of menstrually-associated migraine could significantly improve the lives of women migraineurs," said Lawrence Newman, M.D., of the St. Luke's-Roosevelt Hospital Center Headache Institute in New York, lead investigator of the study. Amerge, marketed by Glaxo Wellcome Inc., is a selective serotonin (5-HT1) receptor-agonist indicated for the acute treatment of migraine attacks with or without aura in adults. It is not indicated for prophylaxic treatment of migraine, including menstrually associated migraine. The incidence of patients who reported a drug-related adverse event was similar across treatment groups, including placebo. Side effects reported in at least two patients (3 percent) treated with Amerge 1 mg or 2.5 mg were dizziness, dyspeptic symptoms, hyposalivation, chest symptoms, malaise and fatigue, paresthesia (a tingling, prickly feeling on the skin) and burning/stinging sensations. None of these events occurred in more than 4 percent of patients. Amerge 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. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g. stable angina or effort and vasospastic forms of angina such as 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 ("TIAs") 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 should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Migraine affects approximately 28 million Americans -- and more than twice as many women as men. Of the women who have migraine, 60 percent report that their headaches are associated with their menstrual cycle. Glaxo Wellcome Inc., based in Research Triangle Park, N.C., is one of the nation's leading research-based pharmaceutical firms. Glaxo Wellcome is committed to leading the attack on migraine by reducing the impact migraine has on the lives of millions of sufferers and, as such, continues to develop better ways to recognize, diagnose and treat migraine. A subsidiary of London-based Glaxo Wellcome plc, the company is committed to fighting disease by bringing innovative medicines and services to patients and to the health-care providers who serve them. Related Link: Glaxo Wellcome Inc.
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