Pharmaceutical Business review

FDA approves new formulation of Glaxo migraine drug

The new formulation allows a convenient way for patients to take a 4mg dose of the drug using the Imitrex STATdose system. Previously patients did not have a convenient way to administer doses lower than 6mg by injection.

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 a 4mg dose of the drug or placebo. This study demonstrated that 67% of patients received headache relief within one hour, compared to 25% for placebo.

“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,” said Dr Robert Kaniecki, director of The Headache Center at the University of Pittsburgh and assistant professor of neurology.