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| |  Imitrex Now Available in Tablet Form in U.S. RESEARCH TRIANGLE PARK, N.C., Sept. 6, 1995 -- The tablet form of Imitrex(R) (sumatriptan succinate), the breakthrough therapy for the acute treatment of migraine, is now available to consumers in the United States by prescription. Since 1993, Imitrex has been available in the U.S. by subcutaneous (beneath the skin) injection form only. Imitrex was developed and is marketed by Glaxo Wellcome Inc. The introduction of Imitrex Tablets will mark availability of the first and only highly selective 5-HT1 (see note) receptor-agonist migraine therapy in a tablet form. In worldwide markets, tablets account for more than 80 percent of sumatriptan sales. "Imitrex is an effective medication with a proven clinical safety profile as evidenced by its use, to date, to treat more than 40 million migraine attacks worldwide," said Richard S. Kent, M.D., chief medical officer, Glaxo Wellcome Inc. "This new oral formulation will provide convenient, effective relief for millions of migraine sufferers who are appropriate patients for Imitrex." Current estimates indicate that over 23 million Americans suffer from migraine, an often debilitating, biological disease that occurs in periodic attacks, with each incapacitating attack lasting from four to 72 hours. Upon its introduction, Imitrex Injection became the first new medication specifically formulated for migraine sufferers in 50 years. 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. Unlike other medications used for migraine, Imitrex has a demonstrated clinical efficacy profile when taken at any point during a migraine attack. Importantly, prompt administration at headache onset may minimize patient suffering. "Imitrex Tablets will enable a spectrum of migraine sufferers to be treated and really decrease the disability that this disease produces for many people," said Dr. Roger Cady, medical director of the Shealy Institute of Comprehensive Health Care in Springfield, Mo., and a clinical investigator of Imitrex. "The ability to use this medication more conveniently is going to play a big role in keeping people at work and keeping them involved in their lives. Of course, Imitrex subcutaneous will remain an effective formulation, especially for patients with attacks characterized by severe nausea and vomiting, or a need for immediate relief -- since it begins to relieve pain and symptoms within ten minutes." In clinical studies with Imitrex Tablets, up to 45 percent of patients had their migraine pain eliminated or reduced as early as 60-90 minutes after taking a 25 mg dose. Clinical studies also showed that up to 83 percent of migraine sufferers (range 68%-83%; average 70%) treated with Imitrex Tablets had the ability to work and function normally or to work while mildly impaired within four hours of taking the medication. Imitrex Tablets have been studied in clinical trials with over 19,400 patients treating more than 102,500 migraine attacks. "Migraines can create large holes in my schedule, sometimes leaving me completely dysfunctional for days at a time, causing me to miss out on family gatherings and work," said Martha Hodgesmith, a migraine sufferer for over 20 years and tablet clinical trial participant. "Imitrex provides the relief I need to maintain my active lifestyle in an easy-to-use tablet. I've been looking for this for a long time." Migraine has a substantial impact on worker productivity. Based on a study of 648 migraine sufferers who sought treatment and met International Headache Society criteria for diagnosing migraine, it is estimated that the annual lost labor costs due to migraine may reach $6,864 per working male and $3,600 per working female. Some sufferers have even chosen less challenging career paths because their migraine attacks are so unpredictable and severe. "Migraines have really interfered in my life. I was often unable to go to work and frequently had to cancel plans with friends at the last minute due to a migraine attack," said Connie Nalls, a tablet clinical trial participant and sufferer who, after experiencing migraines for more than 15 years, initially found relief with Imitrex subcutaneous. "I'm really looking forward to the convenience of taking Imitrex Tablets, but I'm relieved to know the Imitrex Injection is there for me in those situations where I need fast relief." Imitrex mimics certain actions of serotonin, a naturally-occurring neurotransmitter that plays a role in several biological functions in the body, including some in the brain. Serotonin affects nerve cells by stimulating and interacting with various types of receptors, which in turn trigger certain responses in the cells. Unlike other migraine medications, Imitrex selectively activates (as an agonist) the receptors that constrict blood vessels in the head, which are thought to be dilated and distended during a migraine attack. Because Imitrex is highly selective to a particular receptor (5-HT1), it is able to achieve increased therapeutic advantages. Imitrex is available at pharmacies nationwide. The recommended adult dose of Imitrex Tablets is a single 25 mg tablet to be taken with fluids. The maximum single dose recommended is 100 mg. The price that Glaxo Wellcome will charge for each 25 mg tablet dose of Imitrex is $8.95. Imitrex Tablets are indicated for the acute treatment of migraine attacks with or without aura, but not for use in the management of basilar or hemiplegic migraine or cluster headache. Imitrex should only be used where a clear diagnosis of migraine has been established. Imitrex Tablets should not be taken by patients receiving treatment with monoamine oxidase inhibitors (MAOIs), or used within two weeks of stopping therapy with MAOIs. Imitrex should not be used in patients with ischemic heart disease, symptoms or signs consistent with ischemic heart disease, or Prinzmetal's angina because of rare reports of coronary vasospasm. 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 can give rise to increases in blood pressure (usually small). Imitrex should not be used within 24 hours of administration of ergotamine-containing or ergot-type medicines, like dihydroergotamine or methysergide. Imitrex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In clinical trials for Imitrex Tablets, the most common side effects seen included tingling and nasal discomfort. Most side effects are mild and transient. Imitrex Tablets are available in more than 75 countries, including Canada, the United Kingdom and Mexico. Imitrex Injection is also available in more than 75 countries. 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 discovers, develops, and distributes innovative medicines that improve patient health and quality of life. CONTACT: Ramona Jones of Glaxo Wellcome, 919-248-2839
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