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| |  FDA Approves Maxalt For Migraine WEST POINT, PA -- June 30, 1998 -- The United States Food and Drug Administration has approved Merck & Co., Inc.’s Maxalt(R) (rizatriptan benzoate), a new medicine for the acute treatment of migraine with or without aura in adults. Maxalt is the first and only migraine medicine available in both conventional tablets and convenient Maxalt-MLT(TM) tablets, which disintegrate within seconds on the tongue without liquids. The FDA approval of Maxalt was based on four placebo-controlled clinical studies of Maxalt 10 mg (1,167 patients) and 5 mg tablets (977 patients). In these studies, approximately seven in 10 patients who took Maxalt 10 mg reported pain relief at two hours; six in 10 patients who took Maxalt 5 mg reported pain relief at two hours. "A migraine is like a tornado. It attacks fast, usually without warning, and wreaks havoc regardless of what's going on in your life at that moment," says Stephen Silberstein, M.D., director of the Jefferson Headache Clinic in Philadelphia and a clinical investigator for Maxalt. "Maxalt is effective in relieving migraine pain and symptoms. In addition, patients can take the Maxalt-MLT easily and discreetly, even in the middle of a movie or a meeting." Maxalt-MLT orally disintegrating tablets and conventional Maxalt tablets will both be available in 10 mg and 5 mg strengths. There is evidence that the 10 mg dose may provide a greater effect than the 5 mg dose. Clinical studies show that Maxalt provided high rates of pain relief compared to placebo. Across the studies, Maxalt 10 mg relieved migraine pain for 67 percent to 77 percent of patients by two hours, and Maxalt 5 mg relieved migraine pain for 60 percent to 63 percent of patients by two hours. Maxalt also relieved the other migraine symptoms: nausea, photophobia and phonophobia. Maxalt is a medication used only for the treatment of migraine attacks in adults when a clear diagnosis is established. It should not be used to treat headaches that could be caused by other, more serious conditions. Patients should not take Maxalt if they have had a serious allergic reaction to Maxalt or any of its ingredients, have uncontrolled high blood pressure, heart disease or history of heart disease, or symptoms or findings consistent with heart disease. Patients with risk factors for heart disease require a cardiovascular evaluation. Maxalt should not be used within 24 hours of treatment with another drug in this class or with ergotamine-type medicines, or within 14 days of taking a monoamine oxidase (MAO) inhibitor. In a safety database of more than 3,700 patients who received single or multiple doses of Maxalt, Maxalt was generally well tolerated. Side effects were usually mild, temporary and dose related. In studies, the most commonly reported side effects were: dizziness, sleepiness, tiredness, fatigue and pain or pressure (for example, in the chest or throat). About 24 million Americans, a majority of them women, suffer from migraines. Migraines are not just ordinary headaches. Rather, migraines are characterised by attacks of intense, usually one-sided, throbbing headaches that last between four hours and a day or longer. Many sufferers also experience nausea and aggravated sensitivity to light and noise (called photophobia and phonophobia) during a migraine. A small percentage of patients also suffer from vomiting.
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