To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Data Show Nasal Migraine Spray Works Faster Than Oral Drug URL: http://www.pslgroup.com/dg/2CF3A.htm Doctor's Guide June 20, 1997
NEW YORK -- June 20, 1997 -- Clinical study data presented on Amerge® (naratriptan), a migraine therapy currently under development, suggest the tablet is effective as early as one hour and has a long duration of action. Extensive clinical trials with Amerge have consistently shown the 2.5 mg dose is well tolerated because it has a side-effect profile equal to placebo. The drug is awaiting clearance from the U.S. Food and Drug Administration (FDA) and is expected to be available in the U.S. as early as August 1997. The drug's manufacturer, Glaxo Wellcome Inc., these and other results of the latest medical and socioeconomic studies on its upcoming migraine products yesterday at the 39th annual scientific meeting for the American Association for the Study of Headache (AASH). Data was presented on the nasal formulation of Imitrex®(sumatriptan), the only currently marketed 5HT1 receptor-agonist for the acute treatment of migraine. Their data show that the nasal formulation of Imitrex frequently starts providing significant relief as early as 15 minutes after use, faster than oral medications. "Once on the market, Amerge and Imitrex Nasal Spray will join the choice of formulations of Imitrex offered byGlaxo Wellcome to represent a true 'family' of treatment options for physicians and migraine patients. These developments demonstrate our company's commitment to advancing migraine treatment," said Joseph Deveaugh-Geiss, M.D., vice president and international director, CNS clinical research for Glaxo Wellcome. The injection form of Imitrex, introduced in 1993, was the first medication specifically formulated in 50 years for the treatment of migraine. Including the tablet form, introduced in 1995, Imitrex has been used to treat more than 5 million patients and 100 million migraine attacks. It treats the multiple symptoms of migraine and is non-sedating and non-narcotic. Amerge is Long-Acting, Well-Tolerated In a phase III study of 682 migraine patients, more than two-thirds (68 percent) of patients experienced headache relief (severe or moderate pain reduction to mild or none) within four hours of receiving 2.5 mg of Amerge, compared to one-third (33 percent) of patients who received placebo. In patients treated with Amerge who had recurrence, median time to recurrence was 16 hours. Overall, adverse events for both Amerge 2.5 mg (29 percent) and placebo (29 percent) were equal. The New Drug Application for Amerge was filed by Glaxo Wellcome with the U.S. Food and Drug Administration in December 1996, which leads the company to believe that Amerge could receive clearance to market from the U.S. Food and Drug Administration as early as January 1998. Speed and Efficacy of Imitrex Goes Undisputed The data presented regarding the clinical effects of Imitrex Injection demonstrated that the medication is fast, efficacious and consistent. It starts providing significant relief in as early as 10 minutes, the nasal spray as early as 15 minutes and the tablet as early as 30 minutes. At two hours post-dose, efficacy occurs overall in 80 percent of patients using Imitrex Injection, in 70 percent of patients using Imitrex Nasal Spray and in 54 percent of patients using Imitrex Tablets. The side effect profile is the same as that experienced with any 5HT1 receptor-agonist medication, according to Donna L. Gutterman, Pharm.D., CNS U.S. Medical Affairs for Glaxo Wellcome, who presented the Imitrex data at the meeting. "All 'triptans' constrict human coronary arteries and, as such, are not appropriate for patients with cardiovascular disease," she said. "Because we know that this will occur across the entire triptan class, it is essential that physicians understand the importance of appropriate patient selection." Imitrex Helps Patients Return to Work Migraine has a substantial impact on worker productivity. Based on a study of 648 migraine sufferers who sought treatment and met International Headache Society (IHS) criteria for diagnosing migraine, the estimated, annual lost labor costs due to migraine in the U.S. may reach $6,864 per working male and $3,600 per working female. At the AASH meeting, researchers discussed the first-ever study of a migraine medication's effect on work productivity. People taking Imitrex Injection returned to work sooner after migraine struck, and they reached normal productivity faster. In the first two hours after a migraine started, the Imitrex group lost approximately 38 minutes of work, compared to an average 56 minutes lost among patients taking a placebo. After returning to work, performance reached normal levels for 66 percent of Imitrex takers compared to 18 percent of placebo patients, according to the study. "Putting a dollars-and-cents value on pain relief helps everyone understand efficacy," said Gutterman. "As the most studied, most widely used migraine medication, Imitrex has an enormous database documenting the often devastating impact of migraine on lifestyle as well as improvements obtained through the use of Imitrex, including less use of healthcare resources," she said. Migraine and Serotonin Migraine is an often debilitating, biological disease characterized by severe pain, usually on one side of the head, and often accompanied by one or more of the following symptoms: nausea, vomiting, and sensitivity to light, sound and smell. Attacks occur periodically, and can last from four to 72 hours. Many scientists believe that a migraine attack is caused by a sequence of events that causes blood vessels in the brain to tighten, then dilate, resulting in the throbbing pain of a migraine headache. These changes may be caused by alterations in 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. Imitrex mimics certain actions of serotonin. It selectively activates (as an agonist) specific 5HT1D receptors that constrict blood vessels in the head, which are thought to be dilated and distended during a migraine attack. The most common adverse events associated with Amerge were generally mild and transient. These included drowsiness (2.5 percent Amerge; 1.0 percent placebo), dizziness (2.5 percent Amerge; 1.3 percent placebo), fatigue (3.1 percent Amerge; 1.3 placebo) and nausea (4.9 percent Amerge; 4.3 percent placebo). Imitrex Injection is indicated for the acute treatment of migraine attacks with or without aura, but not 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. Imitrex Injection is contraindicated in patients with ischemic heart disease, Prinzmetal's variant angina or symptoms or findings consistent with coronary artery vasospasm, ischemic myocardial disease or other significant underlying cardiovascular disease. 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 also contraindicated in people with uncontrolled hypertension because it may increase blood pressure. Imitrex should not be used within 24 hours of administration of ergotamine-containing or ergot-type medicines, like dihydroergotamine or methysergide. MAO-A inhibitors reduce sumatriptan clearance, significantly increasing systemic exposure. Therefore, co-administration of Imitrex Injection and MAO-A inhibitors is not ordinarily recommended. If such therapy is clinically warranted, the dose of Imitrex Injection should be reduced. Imitrex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In clinical trials for Imitrex Injection, the most common side effects included injection site reactions involving pain, stinging or burning (59%) or atypical sensations (e.g., tingling, warm/hot sensation (42%), dizziness/vertigo (12%), and flushing (7%)). --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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