Sumatriptan Iontophoretic Transdermal System for the Acute Treatment of Migraine

Abstract

SUMMARY We will describe the pharmacokinetic profile, clinical efficacy and safety data of the sumatriptan iontophoretic transdermal system (Zecuity®, NuPathe Inc., PA, USA), recently approved for the acute treatment of migraine with or without aura in adults, by the US FDA. This transdermal system utilizes a low-level electrical current to deliver sumatriptan transdermally and circumvents the GI tract. Pharmacokinetic studies have shown that iontophoretic delivery of sumatriptan achieves detectable plasma concentrations 15 min after activation with a maximum mean serum concentration of 22 ng/ml. A randomized, double-blind, controlled clinical trial demonstrated minimal triptan-related side effects and superior efficacy versus placebo. The pain-free rate at 2 h postdose was 18% of patients applying the sumatriptan patch versus 9% using the placebo (p = 0.0092). This sumatriptan transdermal system may be a good choice for migraineurs with severe nausea or vomiting, those with intolerable triptan-related adverse events and/or those not responding optimally to oral medications.

A novel intranasal breath-powered delivery system for sumatriptan: a review of technology and clinical application of the investigational product AVP-825 in the treatment of migraine

“…Sumatriptan was the first triptan developed and remains the most commonly prescribed medication for the acute treatment of migraine [8,9]. Several formulations of sumatriptan are available in the United States by prescription, including oral tablets, needle and needle-free subcutaneous injection, traditional liquid nasal spray, an iontophoretic sumatriptan transdermal patch, and a combination tablet containing sumatriptan and naproxen sodium [8,[10][11][12]. Sumatriptan suppositories are available in other countries, and orally disintegrating sumatriptan tablets are currently under development [13].…”

The history and rationale of the development of new drugs for migraine treatment

“…35 Triptans may be administered as oral tablets, as dispersive wafers, or atomized intranasally, and sumatriptan is still the only triptan to have a subcutaneous presentation. 35 A transdermic product reached the market 36 but was discontinued due to safety issues. 37 Since 5-HT 1B receptors are located mainly on meningeal vessels, triptans have a tolerability profile far better than ergot alkaloids but are still contraindicated in patients with uncontrolled hypertension, and cardiac and/or peripheral artery disease.…”

Beneath the Skin: A Review of Current Trends and Future Prospects of Transdermal Drug Delivery Systems

“…Iontophoresis has also been used in diagnostic applications, e.g., in the diagnosis of cystic fibrosis using pilocarpine iontophoresis [266] and for monitoring blood glucose levels by reverse iontophoresis [267]. There are some examples of commercially available iontophoretic delivery systems, e.g., Lidosite™ for lidocaine [252], Ionsys™ [268] for fentanyl, Zecuity™ for sumatriptan [269], and a facial spa device by NuFace™ for facial toning without the use of chemical agents [270]. Although iontophoresis does appear to offer numerous advantages, there are still concerns about its safety which are intimately linked to the efficiency of iontophoresis devices.…”