Source: DGNews  |  Posted 1 year ago

By Ed Susman

TORONTO -- April 17, 2010 -- Transdermal delivery of sumatriptan (Zelrix) appears to reduce pain and other symptoms caused by migraines, researchers reported here at the 62nd Annual Meeting of the American Academy of Neurology (AAN).

"The patch may offer significant clinical utility for migraine patients by effectively treating all symptoms of migraine and overcoming the limitations associated with oral, nasal, and subcutaneous delivery of sumatriptan," said Mark W. Pierce, MD, NuPathe Inc., Conshohocken, Pennsylvania, on April 15.

Of the 226 patients who received the sumatriptan patch, 18% were free of pain and 84% were free of nausea after 2 hours, compared with 9% and 63% of the 228 placebo-treated patients, respectively (P = .009 and P < .0001).

In addition, 51% of the patients in the sumatriptan group were free of photophobia and 55% were free of phonophobia after 2 hours, compared with 36% and 39% of placebo-treated patients, respectively (P = .0028 and P = .0002).

Dr. Piece noted that in the study, patients were generally spared the expected sumatriptan adverse events as most pertained to application site pain or rash. Application site pain occurred more in the sumatriptan treatment arm (23% vs 15%). Other frequent adverse events involved application side paraesthesia, pruritus, and application site reactions, which were similar in both the placebo and active treatment groups of patients.

"In about 30% of patients, migraine-associated nausea and vomiting interfere with oral administration of triptans, often resulting in patients delaying or avoiding treatment," Dr. Pierce said. "Additionally, many patients suffer gastroparesis, adversely affecting drug absorption and pharmacokinetics. This results in delayed, inconsistent, or incomplete relief."

He said the single-use, disposable, transdermal patch uses iontophoresis -- a low-level electrical energy -- to facilitate transdermal drug transport. Therefore, the rate and amount of sumatriptan delivered is controlled, thereby achieving consistent dosage and plasma levels with each use.

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 P06.261]