The US Food and Drug Administration has approved a new formulation of GlaxoSmithKline's Imitrex injection that allows a convenient way for patients to take a 4mg dose using the Imitrex STATdose System. Imitrex injection is indicated for the acute treatment of migraines with and without aura in adults.

"The availability of Imitrex Injection provides a simple and effective treatment option for patients who experience certain types of migraines," said Robert Kaniecki, director of The Headache Centre 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," added Kaniecki.

As many as 28 million Americans suffer from migraine headaches.

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..

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, claims a GSK release.

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 per cent of patients received headache relief (defined as reduction in pain from moderate/severe to mild/no pain) within one hour (compared to 25 per cent for placebo), and some reported relief starting in 10 minutes.