Part One: Abuse Liability of Vuse Solo Relative To Combustible Cigarettes And Nicotine Gum

Abstract

Abuse liability (AL) of electronic nicotine delivery systems (ENDS) is relevant as the category increases in popularity as a potentially less-harmful alternative to cigarette smoking. AL assessments are important to the FDA in determining if a new product is appropriate for the protection of public health. This paper reports the results for Vuse Solo and high and low AL-comparators evaluated in an open-label, randomized crossover confinement AL study. The confinement design was adapted from previous ambulatory studies of Vuse Solo and included product familiarization sessions before each four-hour test session in which subjective measures, nicotine uptake, and physiological endpoints were assessed following a single 10-minute ad libitum product use session. Product liking, intent to use again, suppression of urge to smoke, and nicotine uptake were lower after use of Vuse Solo compared to cigarettes and higher after use of Vuse Solo compared to nicotine gum. No significant differences in blood pressure or heart rate were observed between the products pre- to post-product use. These data reinforce previous research showing that Vuse Solo has an AL profile lower than that of combustible cigarettes but higher than that of nicotine gum and may have sufficient AL for product adoption by current adult smokers.

Part Three: Biomarker Changes in Cigarette Smokers Switched to Vuse Solo or Abstinence: A Randomized, Controlled Study

“…The ndings presented in the present study, along with the results reported in the abuse liability study 35 and the nicotine pharmacokinetics study 36 as part of this series, demonstrate that use of Vuse Solo is su cient for product adoption by current smokers. While the results of the subjective measures reported by Campbell et al 35 provide support that Vuse Solo is preferred more than nicotine gum but less than CC, the results of the current study demonstrate that use of Vuse Solo has a favorable impact on reducing toxicant exposure levels relative to smoking, and this impact is comparable to abstinence.…”

“…These data show that Vuse Solo e-liquid consumption remained relatively constant on Days 1 and 2, increased over Days 3 through 5, with a slight decrease from maximum consumption on Days 6 and 7 (Table 2). Across this study and the other two reported as part of this series, 53 total AEs were reported by 68 subjects using Vuse Solo 35,36 . Of these, the study PI determined 11 AEs were possibly related and 9 AEs were related to Vuse Solo use (Supplementary Table S3).…”

“…These results support the concept that smokers who switch to Vuse Solo will use the product in such a way to provide them with levels of nicotine near those of smoking, while reducing their exposure to tobacco-related toxicants found in cigarette smoke. Further evidence to demonstrate that nicotine uptake occurs with Vuse Solo use, but not to the same extent as when smoking a CC, are presented in Campbell et al 35 . In their study, Campbell et al reported on the abuse liability of Vuse Solo, which showed that mean peak nicotine uptake from 10-minute ad libitum use of Vuse Solo was 61% less (p < 0.05) than nicotine uptake from smoking one UB cigarette.…”

“…In the companion papers, Campbell et al report results comparing elements of abuse liability for Vuse Solo to high (CC) and low (nicotine gum) abuse liability comparators 35 , while Hong et al report ndings of a randomized study examining the nicotine pharmacokinetics of multiple avor variants of Vuse Solo 36 . In both studies, CC smokers naïve to the use of ENDS, as well as dual users of CC and ENDS, achieved peak nicotine uptake values that were consistently lower than those for CC and higher compared to nicotine gum with nicotine uptake similar across the assessed avors.…”

“…Results from this study build upon the existing body of research which suggests that exclusive use of ENDS products poses less individual health risk to tobacco product consumers than CC smoking. This paper is the third in a three-part series reporting on three recent studies conducted to evaluate the abuse liability 35 , nicotine pharmacokinetics 36 , and biomarkers of Vuse Solo Gen 2 (current). Adverse event (AE) information for all three studies is collectively reported in this paper.…”