Pharmacokinetic Comparison of a Novel Non-tobacco-Based Nicotine Pouch (ZYN) With Conventional, Tobacco-Based Swedish Snus and American Moist Snuff

Introduction:
This manuscript reports the results of a pharmacokinetic study comparing a novel nicotine pouch product, ZYN®, to conventional tobacco-based snus and American moist snuff. The study aimed to determine the rate and extent of nicotine absorption from these products and to compare the extracted amount of nicotine.

Key Points:

* The study was conducted in two parts, with part 1 comparing ZYN® 3mg and 6mg to 8mg General snus, and part 2 comparing ZYN® 8mg to 18mg Longhorn moist snuff and 2 pouches General snus.
* A single-dose, randomized, cross-over, open-label design was used, with 17 and 29 subjects in parts 1 and 2, respectively.
* Nicotine plasma concentrations were measured at multiple time points, and pharmacokinetic parameters were calculated using non-compartmental analysis.
* The extracted amount of nicotine was determined by analyzing used pouches.
* The study found that ZYN® 6mg and 8mg delivered nicotine as quickly and to a similar extent as existing smokeless products, with no significant adverse effects.
* The extracted amount of nicotine was larger for ZYN® 6mg and 8mg compared to 8mg General snus and 18mg Longhorn moist snuff.
* The extracted fraction of nicotine was also larger for ZYN® 6mg and 8mg compared to 8mg General snus and 18mg Longhorn moist snuff.
* The pharmacokinetic parameters were similar for ZYN® 8mg and 18mg Longhorn moist snuff.

Main Message:
The study provides important information on the pharmacokinetics of a novel nicotine pouch product, ZYN®, compared to conventional tobacco-based snus and American moist snuff. The results suggest that ZYN® 6mg and 8mg deliver nicotine as quickly and to a similar extent as existing smokeless products, with no significant adverse effects. The study also demonstrates that the extracted amount and fraction of nicotine are larger for ZYN® 6mg and 8mg compared to 8mg General snus and 18mg Longhorn moist snuff. The findings may have implications for the development and regulation of novel nicotine products.

Lunell, E., Fagerström, K., Hughes, J., & Pendrill, R. (2020). Pharmacokinetic Comparison of a Novel Non-tobacco-Based Nicotine Pouch (ZYN) With Conventional, Tobacco-Based Swedish Snus and American Moist Snuff. Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco, 22(10), 1757–1763. https://doi.org/10.1093/ntr/ntaa068