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FDA Approves New Formulation of Imitrex (Sumatriptan Succinate) Injection

Patients Can Now Take a 4mg Dose Using the Convenient Imitrex STATdose System(R); Imitrex Injection Offers Fast Relief for Migraine, Starts Working as Early as 10 Minutes

RESEARCH TRIANGLE PARK, NC -- February 2, 2006 -- The United States Food and Drug Administration (FDA) has approved a new formulation of Imitrex (sumatriptan succinate) Injection that allows a convenient way for patients to take a 4 mg dose using the Imitrex STATdose SystemŽ.

Imitrex Injection is indicated for the acute treatment of migraines with and without aura in adults.

As many as 28 million Americans suffer from migraine headaches. Migraines can vary from person to person and from attack to attack, therefore the treatment needs for each attack may also vary. Because relief can mean the difference between debilitating pain and the ability to resume activities of daily life, it is important for migraine sufferers to have a variety of treatment options.

Oral treatments can be effective at treating migraine pain for many patients, but for certain types of migraine attacks, an alternative delivery system, such as an injection, may be a more appropriate treatment choice. These attacks include:

-- Morning migraines -- when patients awaken with an already moderate to severe headache
-- Approximately 48% of migraine attacks occur between 4 a.m. and 9 a.m.
-- Migraines with nausea and/or vomiting
-- Approximately 92% of patients reported experiencing nausea during at least one of their attacks, and approximately 68% reported vomiting during at least one of their attacks
-- Rapidly escalating migraines

"The availability of Imitrex Injection provides a simple and effective treatment option for patients who experience certain types of migraines," said Robert Kaniecki, MD, director of The Headache Center at the University of Pittsburgh and assistant professor of neurology. "Migraine patients who experience nausea or vomiting with their headaches often require an injection, since oral treatments are typically not well tolerated by these patients. Additionally, injections bypass the digestive system and enter the bloodstream quickly, which is especially important for treating certain migraine attacks, such as morning and rapidly escalating migraines."

About The Imitrex STATdose SystemŽ
Imitrex Injection is available in the easy-to-use Imitrex STATdose System, which allows patients to conveniently administer a 4mg dose of Imitrex with just the push of a button. Previously, patients did not have a convenient way to administer doses lower than 6mg by injection.

The Imitrex STATdose System includes two small, disposable cartridges pre-filled with a single dose of Imitrex, and an easy to use autoinjector pen that allows patients to self-administer the medication about one-quarter inch under the skin. With the Imitrex STATdose System patients can treat migraines quickly and conveniently while avoiding direct contact with a needle or syringe.

According to a study published in Headache, 88% of patients found the Imitrex STATdose System easy to use.

"I've suffered with migraines for the last fifteen years and do not respond well to oral treatments due to the nausea I experience with each attack, so I use Imitrex Injection," said migraine patient Kimberly McGonigle. "With the Imitrex STATdose System, I can quickly and easily treat my migraines, so that I can get on with my life."

About Imitrex Injection 4mg
The efficacy of the 4mg dose of Imitrex Injection was established in three double-blind studies of adult patients with acute migraine, with or without aura. In the largest of these studies, 577 migraine patients with moderate to severe migraine pain received Imitrex Injection 4mg or placebo. This study demonstrated that 67% of patients received headache relief (defined as reduction in pain from moderate/severe to mild/no pain) within one hour (compared to 25% for placebo), and some reported relief starting in 10 minutes.

About Imitrex
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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