Plasma Nicotine Pharmacokinetics of Oral Nicotine Pouches Across Varying Flavours and Nicotine Content *

Abstract

SUMMARY Background In recent years several nicotine products have been introduced that aim to offer smokers an alternative to cigarettes. As well as having fewer toxicants than combustible cigarettes, such nicotine products must be able to deliver nicotine efficiently. The aim of this study was to determine and compare the pharmacokinetics of nicotine absorption from nine oral tobacco-free smokeless nicotine pouches with varying nicotine content and flavours. Methods In a randomised, open-labelled, controlled, crossover clinical study, nicotine pharmacokinetics and product-liking were compared between nine nicotine pouches (Velo, BAT; 4- or 7-mg nicotine per pouch and in eight flavours). During a 10-day confinement period, 42 healthy adult participants, who were current smokers of combustible cigarettes, used a single study product once each day during a 45-min use period following overnight nicotine abstinence. Results Maximum plasma nicotine concentration and area under curve for nicotine concentration versus time 180 min after the start of study product use were significantly greater for the 7-mg than for the 4-mg Velo pouches (p < 0.0001). These values did not differ between flavours among the 7-mg Velo nicotine pouches after adjustment for multiple comparisons (both p > 0.003). The median time to maximum plasma nicotine concentrations and mean product-liking scores were similar regardless of nicotine content and flavour. Conclusions Regardless of flavour, nicotine pouches with the same nicotine content and formulation produce similar pharmacokinetic parameters and can deliver nicotine efficiently. Nicotine pouches could be a satisfying alternative for smokers switching from conventional cigarettes. [Contrib. Tob. Nicotine Res. 32 (2023) 130–139]