New Imitrex Formulation!

[Dave ARNP]

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New Formulation of Imitrex (Sumatriptan Succinate) Tablets Now Available in US

New Formulation Designed to Rapidly Release in the Stomach*

RESEARCH TRIANGLE PARK, NC -- February 4, 2004 -- Today, GlaxoSmithKline announced the availability of new Imitrex® tablets, a novel formulation of GSK's leading migraine therapy. The new formulation contains the same active ingredient with the same proven efficacy and safety profile of the conventional Imitrex tablets now with an innovative technology for rapid disintegration of the product in the stomach.

The rapid-release technology of new Imitrex tablets works differently from oral disintegrating tablets, also known as oral melts, which dissolve on the tongue. New Imitrex tablets, which replace the old tablets, are swallowed whole with water like conventional tablets. The new formulation has been designed to dissolve within minutes. In an in vitro study, the new tablet dissolved five times faster than conventional tablets - which may allow the drug to be absorbed into the blood stream quickly. Further studies are needed to establish the relationship between dissolution and efficacy.

Imitrex was the first migraine medication to deliver proven pain-free results. Previous studies with conventional Imitrex tablets showed that 57 percent of patients who treated with 100 mg tablets in the mild pain phase - and 50 percent with 50 mg - were pain free at two hours.

A recent study with the new tablets showed that 66 percent of patients who treated with 100 mg in the mild pain phase - and 51 percent with 50 mg - were pain free at two hours. These results are based on a multicenter-randomized, double-blind, placebo-controlled single-attack study in the intent-to-treat population. Patients (n=432) were instructed to treat during the mild pain phase of their migraine, within one hour of the onset of pain, and to avoid the use of other medications. Not all of these patients complied with these instructions. In a prospective analysis of those patients who did follow the instructions (n=313), 75 percent of patients who took new Imitrex 100 mg tablets (53 percent, 50 mg tablets) reported being pain free at two hours.

Imitrex also treats the associated symptoms of migraine, including nausea, vomiting, and sensitivity to light and sound and were generally well tolerated. In the clinical trial, the most common adverse events reported with new Imitrex 100 mg and 50 mg tablets, respectively, were: nausea and vomiting (5% and

"This new formulation is designed to help overcome the problems associated with gastric stasis, the slow movement of the stomach which commonly occurs during migraine attacks. This condition may slow the absorption of oral medications," said Dr. Frederick Taylor, headache specialist and neurologist at Park Nicollet Health Services (PNHS) and Associate Professor of Clinical Neurology at the University of Minnesota School of Medicine. "A recent clinical trial showed that two-thirds of patients who were instructed to take new Imitrex 100 mg tablets during the mild pain phase were pain free at two hours."

Migraine affects 28 million Americans, 70 percent of whom are women. Imitrex targets the nerves and blood vessels that are believed to trigger the total migraine - pain, nausea, sensitivity to light and sound.

"I see many patients who have endured the painful symptoms of severe headaches for years - thinking they were sinus or tension headaches - before finally coming in for a medical evaluation," said Dr. Susan Hutchinson director and founder, Headache Center Women's Medical Group of Irvine. "Once diagnosed, migraineurs should know that they do not have to suffer and that there are effective treatments, like new Imitrex tablets, available to help patients return to their daily activities."

"GlaxoSmithKline is committed to helping migraineurs and developing new technologies that advance migraine care," said Reijo Salonen, neurologist and vice president of North American clinical development and medical affairs at GlaxoSmithKline. "New Imitrex tablets build on the heritage of the conventional Imitrex, providing effective relief from migraines in a formulation designed to rapidly release in the stomach after swallowing."

Imitrex tablets are approved for the acute treatment of migraines with or without aura in adults and are available by prescription in pharmacies nationwide. Imitrex should only be used when a clear diagnosis of migraine has been established by a physician.

About Imitrex

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 drug in a class of drugs called triptans to receive U.S. Food and Drug Administration (FDA) approval for the acute treatment of migraine in adults.

Imitrex has treated more than 646 million migraines over the last decade, equal to treating a migraine headache 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