Event name:
Tobacco Science Research Conference 2024Session Date:
September 8, 2024 –
Session Speakers:
Session: White Fox 4 mg Nicotine Pouch Products are Bioequivalent to 4 mg Nicorette Lozenge
Speaker: – Ed Carmines, Karen Carmines, Lise Fraissinet, Naama Levy-Cooperman, Ryan Seltzer
Date: September 8th, 2024 – Atlanta, GA
About The Poster:
White Fox brand (GN Tobacco Sweden AB) tobacco free nicotine pouches were tested to determine if the release and absorption of nicotine was equivalent to Nicorette® lozenges. The pharmacokinetics of nicotine absorption from White Fox All White Slim portion and Full Charge All White Regular portion pouches were assessed and compared to a 4 mg Nicorette mint flavor lozenge. A randomized, open label, crossover, in-patient clinical study was performed in 27 subjects to evaluate the nicotine plasma levels. Each study day, subjects used one of the test pouches or one Nicorette lozenge under controlled conditions for 60 minutes. Blood was collected for up to 12 hours. Geometric Least Square (LS) mean Cmax values were similar for White Fox Slim and White Fox Regular when compared to Nicorette lozenge and the 90% confidence interval of the geometric mean ratio of the difference was within the predefined margin of 80% to 125%, indicating bioequivalence. Geometric LS mean AUC0-t values were similar for White Fox Regular when compared with Nicorette lozenge. The 90% confidence interval of the geometric mean ratio of the difference for AUC0-t was within the predefined margin of 0.80 to 1.25, indicating bioequivalence. Geometric LS mean AUC0-t values were also similar for White Fox Slim when compared with Nicorette lozenge; however, for the AUC value, the lower bound of the 90% confidence interval of the geometric mean ratio of the difference was slightly below the predefined margin of 0.80, indicating slightly lower overall exposure for the White Fox Slim product compared with Nicorette lozenge, Since this is a consumer product that is used as desired, any small differences in the bioavailability are not likely to be clinically significant.