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| |  Imitrex Nasal Spray Approved In The U.S. RESEARCH TRIANGLE PARK, N.C. -- September 2, 1997 -- The United States Food and Drug Administration (FDA) has granted its marketing approval to the nasal spray form of Imitrex(R) (sumatriptan) for the acute treatment of migraine. The product is currently available in the United States in subcutaneous injection form and tablet form. This new formulation will offer an alternative for migraine sufferers using oral medications who are seeking rapid relief and/or prefer not to use an injection. In clinical trials, 7 percent to 18 percent of subjects had headache response at 15 minutes and 55 percent to 64 percent at two hours with a 20 mg dose. Imitrex Nasal Spray will be available to consumers by prescription in October, according to the product’s makers, Glaxo Wellcome Inc. Imitrex Nasal Spray is indicated for the acute treatment of migraine attacks in adults with or without aura. Imitrex Nasal Spray is not intended to prevent or reduce the number of migraine attacks nor is it for use in the management of basilar or hemiplegic migraine. Imitrex should only be used where a clear diagnosis of migraine headache has been established. More than 26 million people in the United States suffer from migraine, an often debilitating, biological disease that occurs in periodic attacks, with each attack lasting from four to 72 hours. Since its introduction overseas in 1991 as the first new medication specifically formulated for the treatment of migraine in 50 years, Imitrex has been used to treat more than 133 million migraine attacks in six million patients worldwide. In the United States, Imitrex became available in subcutaneous injection form in 1993; tablets became available in 1995. Imitrex in both formulations is now the most prescribed migraine medication in the United States. Imitrex, a nonsedating, nonnarcotic medication, is the only migraine therapy that treats the multiple symptoms characteristic of migraine, including severe recurrent pain usually on one side of the head often accompanied by one or more of the following: nausea and sensitivity to light and sound. It is equally effective when taken at any point during a migraine headache. "Imitrex Nasal Spray will be a formulation that offers both convenience and effective relief," said C. Phillip O'Carroll, M.D., a neurologist at The Headache Institute in Newport Beach, Calif., who participated in the clinical trials for Imitrex Nasal Spray. Clinical Trials Imitrex Nasal Spray has been studied in clinical trials with more than 3,700 patients to treat more than 10,000 attacks. In these studies 55 percent to 64 percent of patients achieved headache relief at two hours with a 20 mg dose; some patients reported relief in as early as 15 minutes (7 percent to 18 percent). In four of the five studies, there was a significantly greater percentage of patients with headache response at two hours in the 20 mg group when compared with the lower dose groups (5 and 10 mg). In controlled United States clinical trials, patients were highly satisfied with the ease of using Imitrex Nasal Spray. Imitrex Nasal Spray is contraindicated in patients with ischemic heart disease, or symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm including Prinzmetal's variant angina, or other significant underlying cardiovascular disease. Very rarely, certain people have had serious heart related problems, therefore 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 Imitrex is appropriate therapy. Imitrex is contraindicated in patients with uncontrolled hypertension because it may increase blood pressure and should not be used within 24 hours of administration of ergotamine-containing or ergot-type medicines, like dihydroergotamine or methysergide. Imitrex Nasal Spray should not be taken by patients receiving treatment with MAO inhibitors, or used within two weeks of discontinuation of MAO inhibitor therapy. Imitrex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In clinical trials for Imitrex Nasal Spray 20 mg, the most common side effects included bad/unusual taste (24.5 percent, placebo 1.7 percent), and nausea and/or vomiting (13.5 percent, placebo 11.3 percent). Most side effects are mild and transient. In controlled clinical trials, single doses of 5, 10 or 20 mg of Imitrex Nasal Spray administered into one nostril were effective for the acute treatment of migraine in adults. A greater proportion of patients had headache response following a 20 mg dose when compared to a 5 or 10 mg dose. Individuals may vary in response to doses of Imitrex Nasal Spray. However, the choice of dose should be made on an individual basis, weighing the possible benefit of the 20 mg dose with the potential for a greater risk of adverse events. If headache returns, the dose may be repeated once after two hours, not to exceed a total daily dose of 40 mg. -- Imitrex (sumatriptan succinate) Injection is for patients with attacks characterized by severe nausea and vomiting or a need for immediate relief. Imitrex Nasal Spray is currently available in the following countries: Austria, Canada, Denmark, Finland, Luxembourg, Sweden and the UK. The price of Imitrex Nasal Spray will be announced at availability. Glaxo Wellcome Inc., based in Research Triangle Park, N.C., is the nation's leading research-based pharmaceutical firm. 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. More information on: Imitrex, Glaxo Wellcome Inc.
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