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Title: New Research Shows Imitrex (Sumatriptan Succinate) Tablets Formulated With RT Technology Are Absorbed Faster Than Conventional Imitrex Tablets

"New Research Shows Imitrex (Sumatriptan Succinate) Tablets Formulated With RT Technology Are Absorbed Faster Than Conventional Imitrex Tablets"

Technology Facilitates Quicker Delivery of Medication into the Bloodstream PHILADELPHIA, PA -- June 27, 2005 -- New data show that Imitrex Tablets formulated with RT Technology disintegrated six times faster and were absorbed more quickly than conventional Imitrex Tablets. The findings of this study were presented here at the 47th Annual American Headache Society Scientific Meeting. The four-way cross-over pharmacokinetic study of five migraine sufferers compared Imitrex Tablets formulated with RT Technology with conventional Imitrex Tablets. Patients were given a 100-mg radio-labeled tablet with radio-labeled water outside of a migraine attack. Images of the gastrointestinal tract were taken via gamma scintigraphy every minute for the first 30 minutes and every 10 to 15 minutes for four hours. Endpoints were time to disintegration, gastric emptying, and time to onset of absorption. Results from the study showed that the mean time to disintegration was six times faster with Imitrex Tablets, formulated with RT Technology, (6.2 minutes vs. 38.8 minutes) compared to conventional Imitrex Tablets. The mean time to 50 percent gastric emptying was about 30 minutes faster, and at 20 minutes, plasma levels were more than five times higher than conventional Imitrex Tablets. Imitrex Tablets, formulated with RT Technology, are bioequivalent to conventional Imitrex Tablets as measured by AUC0-24 and Cmax. The clinical significance of the scintigraphy data is unknown. "We conducted this study to evaluate if the tablet formulated with RT Technology could deliver faster disintegration and absorption," said Shashidhar Kori, MD, director of clinical development, Neurosciences Medicine Development Center, North America, GlaxoSmithKline, who presented the study findings. "These findings are important because they provide insight into how this delivery technology works in the gastrointestinal tract." Imitrex Tablets, formulated with RT Technology, are designed to enhance the dispersion and dissolution of the active ingredient sumatriptan, even in the presence of gastric stasis. Gastric stasis can delay the disintegration of drugs in the stomach, causing slower absorption of the medication into the bloodstream. "In my experience, many migraineurs prefer oral therapy to treat their migraines," said Sheena Aurora MD, director of the Swedish Headache Center in Seattle, Wash. "However, gastric stasis, a common occurrence in migraine patients, has the potential to limit the efficacy of medicine that is swallowed. Therefore research to identify innovative ways to deliver migraine medication is crucial." These findings are consistent with earlier studies of Imitrex Tablets, formulated with RT Technology. In vitro dissolution studies have shown Imitrex Tablets formulated with RT Technology dissolve five times faster than conventional Imitrex tablets. The clinical significance of the in vitro dissolution data is unknown. About Imitrex Tablets Imitrex is approved for the acute treatment of migraines with or without aura in adults. If the diagnosis is migraine with or without aura, then migraine-specific prescription therapies, like Imitrex, are available for the acute treatment of migraine attacks without drowsiness. Imitrex was the first prescription medication in a class of medications called triptans to receive U.S. Food and Drug Administration (FDA) approval for the acute treatment of migraine in adults. Imitrex has treated approximately 764 million migraines over the last decade, equal to treating two migraine headaches every second. Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes or are a smoker, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor. SOURCE: GlaxoSmithKline

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