A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products

Introduction:
This text is a summary of a scientific study that compares the nicotine pharmacokinetics and product satisfaction of an oral nicotine pouch (NP) to two established nicotine replacement therapies (NRTs), nicotine gum and lozenge. The study aims to determine the bioavailability of nicotine from the NP and the two NRTs and assess the safety and tolerability of the products among healthy smokers.

Key Points:

* The study was a single-center, randomized, three-product, three-period, six-sequence, crossover, single-dose study.
* Thirty-four participants were enrolled, and thirty-two completed the study.
* The NP showed similar nicotine bioavailability to the lozenge (p = 0.6526 for Cmax, p = 1.0000 for AUC 0-T) and superior bioavailability to the gum (p < 0.0001 for Cmax 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).
* The NP may provide smokers with a more satisfying alternative nicotine source as compared to the reference NRTs.
* The health risks of cigarette smoking are well-known, and chronic smoking-related disorders are a result of the long-term inhalation of tobacco smoke.
* Nicotine replacement therapies (NRTs) are intended for short-term use to help cigarette smokers to quit, but 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.

Main Message:
The study suggests that oral nicotine pouches (NPs) may provide smokers with a more satisfying alternative nicotine source as compared to the reference NRTs. The NP showed similar nicotine bioavailability to the lozenge and superior bioavailability to the gum. Compared with the lozenge, the NP demonstrated greater product satisfaction with a higher number of positive responses to subjective satisfaction questions. All products were well-tolerated, and the incidence of minor adverse events was lower for the NP. The study also highlights the health risks of cigarette smoking and the potential of NRTs as a short-term intervention to help an individual switch from cigarette smoking to complete abstinence. However, the study also acknowledges that quitting smoking is not easy, and many smokers may need to try several times before they are successful. Therefore, the development of potentially reduced risk tobacco and nicotine products, such as e-cigarettes and tobacco heating products, has been supported by public health authorities as a way to prevent or reduce the health risks of cigarette smoking for individuals and populations.

Azzopardi, D., Ebajemito, J., McEwan, M., Camacho, O. M., Thissen, J., Hardie, G., Voisine, R., Mullard, G., Cohen, Z., & Murphy, J. (2022). A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products. Scientific Reports, 12(1), 6949. https://doi.org/10.1038/s41598-022-10544-x