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.
Data from a Phase I study that compared the patch to sumatriptan in nasal spray, oral tablet and subcutaneous injection formulations showed that the patch had fewer side effects than sumatriptan taken orally or via injection. None of the 17 subjects using the patch reported such sensations as flushing, pain or pressure, which are occasionally seen with the injection and pill forms. The most common adverse event from the patch was itching at the patch application site.
In addition, plasma concentrations of sumatriptan were more consistent than with tablets or nasal spray, meaning the drug reached the body in a more predictable and consistent way. Mark Pierce, MD, PhD, chief scientific officer at NuPathe, said the results show that transdermal delivery “provides a more predictable method of drug delivery by bypassing absorption through the gastrointestinal system.”
Large Phase III trials to evaluate the effectiveness and safety of Zelrix are now underway.
The results of the study are forthcoming in the journal Headache.