FDA approves GlaxoSmithKline's Imitrex injection

By Lisa Kerner

Erie, Pa., Feb. 2 - The Food and Drug Administration has approved a new formulation of GlaxoSmithKline's Imitrex Injection, according to a company news release.

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

Imitrex Injection, available in the Imitrex STATdose System, allows patients to conveniently administer a 4mg dose of Imitrex by pushing a button. The system includes two small, disposable cartridges pre-filled with a single dose of Imitrex. An autoinjector pen enables patients to self-administer the medication about one-quarter inch under the skin, the company said.

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. The study demonstrated that 67% of patients received headache relief within one hour, compared to 25% for placebo. The company said some patients reported relief starting in 10 minutes.

An alternative delivery system, such as an injection, may be a more appropriate treatment choice than oral treatments for morning migraines, rapidly escalating migraines, and migraines with nausea and/or vomiting, the company said.

GlaxoSmithKline is a pharmaceutical and health care company based in London.

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