Source: DGNews  |  Posted 2 years ago

By Liz Meszaros

PHILADELPHIA -- September 12, 2009 -- A novel iontophoretic transdermal patch delivery system of sumatriptan provides rapid, efficacious treatment of acute migraine without many of the disadvantages associated with oral, nasal, and subcutaneous formulations of sumatriptan, according to a study presented here at the 14th Congress of the International Headache Society & the 51st Annual Scientific Meeting of the American Headache Society (IHS/AHS).

The new delivery system (a combination of drug and device) is a single-use, disposable, transdermal patch that delivers sumatriptan via iontophoresis, using low-level electrical energy to transport drug treatment across the skin.

“The patch contains the drug and a small microprocessor that provides an electrical current that drives the drug across the skin into the system,” said co-author Mark W. Pierce, MD, NuPathe Inc., Conshohocken, Pennsylvania, on September 11. “The patch is applied and activated by the patient, and then stays active for 4 hours.”

The randomised, parallel-group, double-blind, placebo-controlled, phase 3 study included 454 patients aged 18 to 66 years, with International Headache Society-defined migraine headache, who experienced moderate to severe headaches and had a >=1 year history of migraines.

Patients were randomised to treat a single moderate to severe migraine attack with the iontophoretic transdermal sumatriptan patch or placebo.

A significantly higher number of patients treated with the iontophoretic sumatriptan patch were headache-pain free 2 hours after patch activation, compared with placebo (19% vs 9%, respectively; P = .009). This significant difference from placebo continued for all subsequent time points up to and including 12 hours after patch activation (P <= .0357).

The iontophoretic sumatriptan patch was also associated with a significantly higher proportion of patients reporting headache pain relief as early as 1 hour following patch activation, compared with placebo (29% vs 19%; P = .0135).

In addition, a significantly higher proportion of patients treated with the iontophoretic sumatriptan patch were nausea-free within 1 hour compared with placebo after patch activation (71% vs 58%; P = .0251). This difference was maintained for up to 12 hours.

Within 2 hours of iontophoretic sumatriptan patch activation, a significantly greater number of patients were photophobia free (51% vs 36%; P = .0028) and phonophobia free (55% vs 39%; P = .0002), compared with placebo.

The iontophoretic sumatriptan transdermal patch was well tolerated, with the most common adverse event being application-site reactions, including pain, paresthesia, pruritus, and site reactions. These resolved within 2 days.

The incidence of adverse events was similar between the groups treated with the iontophoretic sumatriptan patch and those treated with placebo (51% vs 45%). The incidence of triptan-specific adverse events that are typically associated with sumatriptan plasma levels of greater than 50 ng/mL, however, was very low in those treated with the iontophoretic sumatriptan transdermal patch (2%).

“Our trial clearly shows that this method of delivery is very effective for migraine,” concluded Dr. Pierce.

Funding for this study was provided by NuPathe Inc.

[Presentation title: Acute Anti-Migraine Efficacy and Tolerability of Zelrix, a Novel Iontophoretic Transdermal Patch of Sumatriptan. Abstract PO23]