Imitrex(R) (Sumatriptan Succinate) Injection 6 Mg Provides Consistent Pain-Free Relief of Morning Migraine and Associated Symptoms, Studies Show

Market Wire, June, 2003

More than 28 million Americans suffer from migraine(1), and 42 percent(2) of those (nearly 12 million people) report that they have experienced morning migraine -- a condition in which moderate to severe pain and other symptoms force patients to awaken from sleep. Now, according to new data released today, morning migraineurs may find fast relief from moderate to severe pain and associated migraine symptoms with Imitrex Injection. The data were presented at the 45th annual American Headache Society meeting in Chicago.

"Morning migraine is often an indicator of a 'lost day.' It not only interrupts sleep, but it often debilitates patients for hours at a time and interferes with regular activities, like going to work or dropping the kids off at school," said Dr. James Adelman, FACP, one of the investigators and director of the Headache Wellness Center in Greensboro, N.C. "The studies showed that after taking Imitrex Injection, a significant number of patients reported being pain-free and returned to their normal activities within two hours. Additionally, some patients reported an onset of pain relief (mild or no pain) beginning in 10-20 minutes and onset of pain-free relief in 20-30 minutes. Simply, this treatment quickly puts the day back on track."

Migraine is a neurobiological disorder that affects 28 million Americans and can result in missed days of work, lost time with family and friends and a disrupted daily routine. Migraine is characterized by symptoms including moderate to severe headache pain, nausea, vomiting and sensitivity to light and sound.

Headache is one of the most common causes for work absenteeism; migraineurs miss more than four workdays per year(3). Forty-eight percent of migraine attacks occur between 4 a.m. and 9 a.m., and one out of seven migraine attacks awaken patients from their sleep due to severe pain(4).

About the Studies

Two identical randomized, double-blind, placebo-controlled, single-attack studies were conducted to determine the pain-free efficacy of Imitrex Injection versus placebo in the acute treatment of migraine that is moderate to severe upon awakening. Patients (n = 584) were included if they had experienced a morning migraine at least once in the preceding three months and had successfully treated a migraine in the past with a 5-HT1 agonist but had not used an injection formulation.

Patients were randomized to receive Imitrex Injection or placebo to treat a single migraine attack within one hour of awakening with moderate to severe migraine pain. The primary efficacy endpoint was the percentage of subjects pain-free (moderate or severe pain reduced to no pain) at two hours after dosing. Also assessed were migraine-free relief (no pain or associated symptoms) and adverse events.

About half of the patients treated with Imitrex Injection reported being completely pain or migraine-free two hours after treatment.

About Imitrex

If the diagnosis is migraine, then migraine-specific prescription therapies, like Imitrex (sumatriptan succinate), which is manufactured by GlaxoSmithKline, are available to treat the pain and associated symptoms of migraine without causing sedation. 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. It should only be used where a clear diagnosis of migraine has been established.

Imitrex is contraindicated in patients with history, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive Imitrex. Patients with risks 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 health care provider to determine if Imitrex is appropriate therapy. Imitrex is contraindicated in patients with uncontrolled hypertension because it may increase blood pressure.

Imitrex and any ergotamine-containing or ergot-type medication should not be used within 24 hours of each other, nor should Imitrex be used with another 5-HT1 agonist.

Patients should consult with their health care provider before using Imitrex if they are pregnant or nursing.

These studies were sponsored by GlaxoSmithKline. As one of the world's leading research-based pharmaceutical and health care companies, GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. U.S. operations are in Philadelphia, Penn., and Research Triangle Park, N.C.

Note to Editors:

Please consult full prescribing information. For complete prescribing information for Imitrex Injection, please contact:

Claire Anselmo

DeVries Public Relations
(212) 891-0455

canselmo@devries-pr.com

or

Robin Gaitens
GlaxoSmithKline
(919) 483-2839