A Single-Dose, Crossover-Design Bioequivalence Study Comparing Two Nicotine Gum Formulations in Healthy Subjects

INTRODUCTION: Nicotine replacement therapy (NRT) benefits smokers who wish to quit; nicotine gum represents one NRT. New formulations of nicotine gum have been developed to consider consumer preferences and needs. A new mint-flavored nicotine gum with a different texture was developed that may provide a more appealing taste and chewing experience. This study evaluated this new nicotine gum (2 and 4 mg strengths) for bioequivalence versus the original flavor sugar-free nicotine gum at corresponding dosages. METHODS: All subjects randomized in this crossover study received a single dose of all treatments, i.e., 2 and 4 mg doses of test and reference gums, separated by 2–7 days of washout between treatments. Subjects’ maximal plasma nicotine concentration (C(max)) and extent of nicotine absorption (AUC(0–t)) following the administration of each treatment were calculated from plasma nicotine concentrations. Ratios of test/reference for C(max) and AUC(0–t) were calculated to evaluate bioequivalence between the two products. RESULTS: Both 2 and 4 mg doses of the new mint-flavored nicotine gum were bioequivalent to the dose-matched reference product as determined by the ratio of the geometric means and their 90% confidence intervals for C(max) and AUC(0–t) as well as secondary pharmacokinetic parameters. The safety profiles of the test and reference gums were similar; all treatments were well tolerated. CONCLUSIONS: A new mint-flavored nicotine gum with modified taste and texture is bioequivalent to the original flavor sugar-free nicotine gum at both the 2 and 4 mg dosage strengths and has a similar safety profile. FUNDING: GlaxoSmithKline. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01847443.