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.

Financial & competing interests disclosure

M Vikelis has consulted for, advised or spoken for Allergan, AstraZeneca Hellas, Janssen-Cilag Hellas and Novis Pharmaceuticals Hellas, and is currently an employee of Novartis Hellas SACI. DD Mitsikostas is on advisory boards of Allergan, AstellasPharma, Bayer-Shering Hellas, Genesis Pharma, Merck Hellas and Novartis Hellas; he has received honoraria from Menarini; has received payment for development of educational presentations including service on speakers‘ bureaus for Eli Lilly; and has received travel/accommodation expenses covered or reimbursed from Janssen-Cilag, MSD, Novis, Pfizer and UCB. AM Rapoport has consulted or spoken for Allergan, Dr Reddy‘s, Impax, MAP, Merck, Nautilus Neurosciences, NuPathe, Transcept, Winston and Zogenix. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance or other support was utilized in the production of this manuscript.

Additional information

Funding

M Vikelis has consulted for, advised or spoken for Allergan, AstraZeneca Hellas, Janssen-Cilag Hellas and Novis Pharmaceuticals Hellas, and is currently an employee of Novartis Hellas SACI. DD Mitsikostas is on advisory boards of Allergan, AstellasPharma, Bayer-Shering Hellas, Genesis Pharma, Merck Hellas and Novartis Hellas; he has received honoraria from Menarini; has received payment for development of educational presentations including service on speakers‘ bureaus for Eli Lilly; and has received travel/accommodation expenses covered or reimbursed from Janssen-Cilag, MSD, Novis, Pfizer and UCB. AM Rapoport has consulted or spoken for Allergan, Dr Reddy‘s, Impax, MAP, Merck, Nautilus Neurosciences, NuPathe, Transcept, Winston and Zogenix. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.