Imitrex Nasal Spray Now Available For Migraine In U.S.
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Imitrex Nasal Spray Now Available For Migraine In U.S.

RESEARCH TRIANGLE PARK, NC -- November 28, 1997 -- The nasal spray form of Imitrex(R) (sumatriptan), the innovative therapy for the acute treatment of migraine, is now available to consumers in the United States by prescription.

Imitrex has been available in the U.S. since 1993 in subcutaneous injection form and since 1995 in tablet form. The medication was developed and is marketed by Glaxo Wellcome Inc.

This new formulation offers an alternative for those who are dissatisfied with oral medications and/or prefer not to use an injection.

Imitrex Nasal Spray is indicated for the acute treatment of migraine attacks in adults with or without aura. The drug 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 U.S., 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 U.S.

Imitrex, a non-sedating, non-narcotic 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. Imitrex is equally effective when taken at any point during a migraine headache. It is the only migraine therapy available in three different formulations.

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.

In four out 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 mg and 10 mg). In controlled U.S. 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, even some without heart disease, 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.

More information on: Imitrex, Glaxo Wellcome Inc.

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