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| |  New Imitrex Self-Administration Device Now Available In U.S. RESEARCH TRIANGLE PARK, N.C., April 9, 1997 -- The Imitrex(R) (sumatriptan succinate) STATdose(TM) System, a compact, easy-to-use injector unit for self-administration of Imitrex Injection, a breakthrough therapy for the acute treatment of migraine, is now available to consumers in the United States by prescription. The device marks the next step in the continuing efforts of Glaxo Wellcome Inc. to advance therapy for many of the 23 million people in the United States who suffer from migraine, an often debilitating, biological disease that occurs in periodic attacks, with each attack lasting from four to 72 hours. The company developed and markets Imitrex Injection which, upon its introduction in the U.S. in 1993, was the first new medication specifically formulated for the treatment of migraine in 50 years. It remains the only commercially available highly selective 5-HT1 (see note 2 below) receptor-agonist for migraine treatment. An oral formulation of Imitrex became available in 1995. STATdose System is designed to increase ease of use for patients who have been prescribed Imitrex Injection, which is delivered by subcutaneous injection (beneath the skin). The device is packaged in a slim 2 3/4" x 4 3/4" carrying case, about the size of a standard cassette tape, and can fit into virtually any pocket or pocketbook. The case is made of sturdy plastic and contains an injector pen and a cartridge with two, single-dose syringes of Imitrex Injection, each protected by a tamper-evident seal. The STATdose PEN features a mechanism that mimics that of a ball-point pen and eliminates several steps over a previous autoinjector. Users need only follow a few simple steps: remove the hollow pen from the carrying case; place it over one of the single-dose syringe cartridges, twist to lock in place and extract; place the pen against the thigh or upper arm (deltoid muscle) and press a button at the top of the device (as one would a pen) to inject the medication; replace the used syringe cartridge in the cartridge pack and dispose of when convenient. With the STATdose PEN, the needle is not exposed until after the injection is administered, and a syringe is never handled directly. In clinical trials, 84-88 percent of patients considered the device easy to use. "When my patients are suffering, rapid relief is vital. Therefore, a major reason I believe Imitrex Injection is such an effective medication for the treatment of migraine is that it begins to relieve pain and symptoms within ten minutes," said Lawrence Robbins, M.D. of the Robbins Headache Clinic in Northbrook, Ill. "The STATdose System combines the speed-of-onset with the ease and convenience, both major factors in allowing patients to move quickly to reduce the level of impact this disease can have, and to keep them productive and in control of their lives." "For me, the method is as important as the medication," said Sue Chaikin, a clinical trial participant and sufferer who feels that because of the compact size of the device, she will now be ale to keep the Imitrex STATdose System with her at all times. "When an attack begins, the last thing I want to worry about is difficulty in taking my medication. The STATdose System is so easy to use, I never live in fear of my next attack -- I am confident that I can manage my migraine quickly and that my day can continue uninterrupted." 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 and one or more of the following: nausea, vomiting and sensitivity to light. Imitrex has a demonstrated clinical efficacy profile when taken at any point during a migraine headache. Imitrex has a proven clinical safety profile and has been used to treat more than 40 million migraine attacks worldwide. Imitrex Injection is available in more than 50 countries, including the United Kingdom, Canada, China, Italy and Holland. The STATdose System was first introduced in Finland in February 1994, and is currently available in France, Germany, the Netherlands, Norway, Sweden and the U.K. The STATdose System is for use only by patients prescribed a 6 mg dose of Imitrex. Single-dose vials of Imitrex are also available for use by health-care providers who administer Imitrex Injection to patients or for those patients who require a dose less than 6 mg. Migraine patients who have additional questions about the Imitrex STATdose System may call the Glaxo Wellcome consumer affairs information line at 800-437-0992. Glaxo Wellcome Inc., based in Research Triangle Park, N.C., is a research-based pharmaceutical firm.
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