The FDA Rejects the Application for Levadex

Last month the U.S. Food and Drug Administration (FDA) rejected Levadex ®, an inhaled form of the migraine medication, dihydroergotamine (DHE). This is the second time the agency has failed to approve the medication.

DHE has been used in migraine treatment for many years, but it is most effective when given intravenously or via intramuscular injection, requiring a hospital or clinic visit. A DHE nasal spray is also available but is slow to take effect. The inhaled form of the medication is meant to work quickly and can be used at home. Continue Reading


Taking Your Triptan with a Patch

One of the most active areas of research in the treatment of migraine is searching for new ways to deliver established drugs to make them more effective and to reduce side effects. A new product in development by NuPathe, called Zelrix®, would deliver sumatriptan (the active ingredient in Imitrex®) through the skin via a transdermal patch. The patch would allow the drug to take effect without having to go through the gastrointestinal system, which is typically under duress during migraine. Continue Reading


Imitrex – Sumatriptan

Imitrex is the first of a class of medications commonly referred to as the triptans. It is a specific medication for aborting migraine headaches. It is also effective in cluster headache as an abortive medication. It appears to act in migraine by binding to selected receptors for serotonin found in the blood vessels (5HT1b) and nerve endings (5HT1d). By binding to these receptors it keeps the migraine from developing or causes it to end. It does not appear to stop migraine auras.

Sumatriptan has been available in the United States since 1993. Formulations include a self-administered injection given under the surface of the skin (subcutaneous), nasal spray or oral tablets. In 2004, the tablets were reformulated to dissolve more quickly in the stomach. They are still swallowed as a conventional tablet, not an orally dissolving product. The injectable form is very rapid in its onset of action and can stop a migraine in 15 minutes in some patients. The oral form is slower and usually reaches its maximum effect within two hours. The nasal spray is somewhere between the other two in the amount of time it takes to begin working. Continue Reading