A direct comparison of two transdermal nicotine systems: Clinical pharmacokinetic performance

Authors:
Angela M. DeVeaugh-Geiss, Lilan H. Chen, Mitchell L. Kotler, Lisa R. Ramsay, Michael J. Durcan

Presenter:
Angela M. DeVeaugh-Geiss
Principal Clinical Research Scientist, GlaxoSmithKline, New Jersey, USA

Abstract
This single-center, randomized, open label, single dose, two-way crossover study compared the pharmacokinetic profile of NiQuitin/NicoDerm CQ (21 mg/24 hour [hr]) and the new 25 mg Nicorette Invisipatch (25 mg/16 hr). Eligible subjects were domiciled for the entire study; no smoking was permitted during the baseline and treatment sessions. Blood samples were obtained at predetermined time points pre- and post-dosing. The primary pharmacokinetic parameter was AUC0-inf, to compare the total nicotine exposure. Secondary pharmacokinetic parameters, including Cmax and tmax, as well as post hoc exploratory parameters, AUC0-16 and AUC0-inf assuming a 16 hour application for the 21 mg/24 hr patch, were also explored. The 21 mg patch delivered more nicotine than the 25 mg/16 hr patch when used as directed: the AUC0-inf was significantly (57%) higher for the 21 mg/24 hr patch than the 25 mg/16 hr patch [382 vs. 244 ng/ml•hr; ratio of geometric means (90% Confidence Interval): 157% (148%, 166%)]. Additionally, the 21 mg/24 hr patch reached maximum concentration earlier than the 25 mg/16 hr patch (6 vs. 12 hours, respectively, p<0.0001). The Cmax, AUC0-16, and AUC0-inf assuming a 16 hour application for the 21 mg patch were also significantly higher for the 21 mg vs. 25 mg patch. Both patches were well-tolerated. This study provides further support that there are differences among the marketed nicotine transdermal patches.

Source of funding: This study was sponsored by GlaxoSmithKline Consumer Healthcare.

Declaration of interest: The authors are all paid employees of GlaxoSmithKline Consumer Healthcare.