Lexaria Bioscience reports results for human oral nicotine study NIC-H22-1

Lexaria Bioscience reports results from its 2023 human oral nicotine study NIC-H22-1 comparing Lexaria’s DehydraTECH-Nicotine tobacco-free pouch to brands ZYN and on! Lexaria’s oral nicotine pouch was statistically significantly faster in the median time required to reach comparable maximum nicotine concentrations within the bloodstream, than both on! and ZYN. DehydraTECH-Nicotine was 15.0% faster in reaching Tmax levels than on! and 20.2% faster than ZYN. According to a pharmacokinetic study, both combustible cigarettes and “heat-not-burn” tobacco-containing devices require roughly 8 minutes to reach Tmax. Using this standard cigarette Tmax delivery time as a base, the ZYN pouch was 131% slower and the on! pouch was 121% slower than a smoked cigarette to reach Tmax. The Tmax times of a number of nicotine product formats at comparable dose levels used in study NIC-H22-1 are shown in the table below, taken from the published 2009 study Nicotine Chemistry, Metabolism, Kinetics and Biomarkers, showing the relative Tmax time delay per product compared to cigarette use. Generally speaking, rapid delivery of nicotine is a vital component of the potential for product adoption for use by consumers. Avoiding or minimizing harm is a major objective of oral nicotine products. Another study reported that heat-not-burn devices delivered as much as 27.9% of the same harmful and potentially harmful constituents delivered by combusted cigarettes. These include substances such as nitrosamines and polycyclic aromatic hydrocarbons such as benzene. By comparison, non-combusted oral nicotine pouch products with no tobacco and nicotine replacement therapies, have been shown to deliver non-quantifiable levels of these harmful substances for superior safety and tolerability. The FDA has indeed issued a reduced-risk notice for smokeless type products. Detailed questionnaires were administered to all participants in the study, for each test article, to assess subjective effects and determine the “human experience” while using the products. While the findings lacked statistical significance in most instances, possibly due to sample size limitations, a number of intriguing data trends were observed. In general, the fact that the Tmax was faster with Lexaria compared to both on! and ZYN, seemed to support apparent trends towards higher levels of certain pleasurable effects, sooner, with the Lexaria product. Conversely, the lowest frequency of certain unwanted negative effects such as moderate to severe nausea were reported from the Lexaria product users, demonstrative of some of the patented formulation benefits of Lexaria’s DehydraTECH. Euphoria and Head Rush. The highest percentage of users reporting that they felt euphoric at all time points were the Lexaria users; and the highest percentage of users reporting they felt a head rush at the 5 and 30-minute marks were also Lexaria users. Tolerability. The highest endorsement score for users reporting “I tolerated this product well” were the Lexaria users, with statistical significance demonstrated at the second dosing visit in particular. Pleasure. The highest percentage of users reporting that they considered the experience “pleasurable” at the 30-minute mark were the Lexaria users, while the on! users reported the lowest percentage as “pleasurable” at this point. Mouth and Throat-burn. Lexaria scored best for percent enjoyment of the nicotine induced burning sensation in the mouth and throat. The highest percentage of severe mouth and throat-burn events were reported by users of the on! pouch. Nausea. The highest frequency of moderate and severe nausea effects were reported by users of the ZYN and on! pouches respectively; with the lowest frequency reported by users of the Lexaria pouch. Hiccups. Moderate to severe hiccups were only reported by users of the on! and ZYN products. Lexaria will now seek to commercialize DehydraTECH-Nicotine with suitable industry partners based on its clinical and intellectual property advancements.