Imitrex DFT - Aims to Deliver What Patients Want Most: Speed to Zero Pain

Millions of Canadians Can Experience the Migraine Free Way

MISSISSAUGA, ON (September 22, 2004) -- In today's fast-paced world, everyone is looking for the quick answer - especially the millions of Canadians who suffer from migraine. GlaxoSmithKline Inc. today announced that Health Canada has approved Imitrex DFT for the treatment of migraine. The new formulation contains the original active ingredient, with the same proven efficacy and safety of the conventional Imitrex® tablet (sumatriptan succinate), but with an innovative technology designed to facilitate disintegration in the stomach.

Imitrex, the first of the medications known as triptans, was approved in Canada in 1992, and continues to be the most prescribed medication of its kind. Imitrex DF tablets are swallowed whole with water and break apart in the stomach within minutes, allowing the drug to be rapidly absorbed into the bloodstream.

"Migraine headaches have a significant impact on my quality of life. They affect my ability to make plans with friends; they affect my relationship with my son. Migraine impacts every aspect of my life," said Anne Fox, a migraine sufferer for 25 years. "I literally never go anywhere without Imitrex, and the new Imitrex DF will certainly be a welcome option."

With Imitrex DF 100 mg tablets, close to 45 per cent of migraine attacks were reduced to zero pain at one hour, and 66 per cent were reduced to zero pain at two hours, in a clinical study* where patients were instructed to treat migraine during the mild pain phase. Statistically significant zero pain results were seen when compared to placebo as early as 30 minutes with Imitrex DF (Imitrex DF 100 mg vs. placebo, p<0.01).

Innovative Technology

Migraine attacks can affect the digestive system delaying the absorption of medications taken orally. Imitrex DF is designed to work well under these conditions. The Imitrex DF tablets are swallowed whole with water like the conventional Imitrex tablets, and break apart in the stomach within minutes.

"Anyone who suffers from migraine wants their treatment to work fast. Imitrex DF is designed to facilitate disintegration in the stomach, which may provide benefit to the patient," said Dr. Gary Shapero, Medical Director of the Markham Headache and Pain Treatment Centre, Ontario, Canada. "I look forward to this new formulation, which builds on the proven history of Imitrex to help patients quickly return to their daily lives."

About Migraine

Migraine, a neurological condition that results in periodic attacks of neurovascular headache, results in missed workdays, lost family and social time, and disrupts the daily lives of more than three million Canadians. Approximately three times as many women as men suffer from migraine.

About Imitrex DF

Imitrex DF is approved for the acute treatment of migraine with or without aura (a visual disturbance that occurs prior to the onset of migraine pain) in adults and is available by prescription in pharmacies nationwide. Imitrex DF should only be used when a clear diagnosis of migraine has been established by a physician.

Imitrex DF also treats the associated symptoms of migraine, including nausea, vomiting, and sensitivity to light and sound and is generally well-tolerated.

Imitrex DF will replace the traditional oral tablets, to join the family of successful Imitrex medications, which also includes nasal spray and injection formulations.

GlaxoSmithKline

ED - the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance[4] - is a common health condition among men that is largely untreated. It is estimated that some degree of ED affects more than one half of all men over the age of 40[5] - 152 million men worldwide[6] and three to four million men in Canada alone.[7] Despite the high prevalence of sexual problems, only 12 per cent of men worldwide have received treatment.[8]

About Bayer HealthCare

GlaxoSmithKline Inc. - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. In Canada, GlaxoSmithKline is a top 20 investor in Canadian research and development, contributing more than $100 million annually. The company is also among the top 10 corporate charitable donors and is recognized as one of the 50 best companies to work for in Canada.

Imitrex DFT is a trademark, used under license by GlaxoSmithKline Inc.

For more information please contact:

Rebecca Holohan / Katarina Mayer

Edelman

416-979-1120, ext. 320 / 222

Sylvie Lafrance / Daphne Weatherby

Edelman (Quebec)

514-844-6665, ext. 244 / 225

Alison Steeves / Catherine Jackson

GlaxoSmithKline Inc.

905-819-3363

Editor's Note:

Canadian Migraine Facts

  • More than 15 per cent of Canadians between 18 and 65 years old suffer from some form of migraine.
  • Migraine headaches affect three times as many women as men.
  • Some common migraine triggers include:
    • Alcohol (especially red wine)
    • Dairy products (especially cheddar cheese)
    • Fatty or fried foods
    • Food additives
    • Shifts in weather (e.g., a sudden change in climate)
    • Hormonal factors (e.g., puberty, menstruation, pregnancy, menopause)
    • Oral contraceptive use
    • Stress (extreme emotions - positive or negative)
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