A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products
David Azzopardi, James K. Ebajemito, Michael McEwan, Oscar M. Camacho, Jesse Thissen, George Hardie, Richard Voisine, Gavin Mullard, Zvi R. Cohen, James J. Murphy
Abstract
Abstract Nicotine replacement therapies (NRTs) are intended for short-term use to help cigarette smokers to quit. Some smokers find NRTs ineffective or seek a more satisfactory source of nicotine. Tobacco-free oral nicotine pouch (NP) products have emerged as a potential reduced risk product compared with cigarettes and other tobacco products. In a randomised crossover clinical study, thirty-four healthy adult smokers were enrolled and their nicotine C max and AUC 0-T determined for three 4 mg nicotine products (NP, gum, lozenge) under fasting conditions. The NP, lozenge and gum mean C max values were 8.5, 8.3 and 4.4 ng/mL, AUC 0-T values were 30.6, 31.5 and 14.3 ng*h/mL, respectively. The NP showed similar nicotine bioavailability to the lozenge ( p = 0.6526 (C max ), p = 1.0000 (AUC 0-T )), and superior bioavailability to the gum ( p < 0.0001 for C max and AUC 0-T ). Compared with the lozenge, the NP demonstrated greater product satisfaction with a higher number of positive responses to subjective satisfaction questions. All products were judged to be well-tolerated; the incidence of minor adverse events was lower for the NP (18.2%) than the lozenge (33.3%) or gum (18.8%). In summary, NPs may provide smokers with a more satisfying alternative nicotine source as compared to the reference NRTs. Study Registry/Registered Trial No: ISRCTN/ISRCTN65708311.