Lexaria Bioscience Corp.
Speed of onset is a key attribute for oral drug administration, and it is of particular importance for the consideration of non-inhalation nicotine delivery formats.
Lexaria contracted a third-party laboratory to perform the study which focused on detailed analysis of absorption over a 60-minute period, with particular emphasis on the first 15-minutes after dosing (n=40; two groups of 20 rats per group; nicotine polacrilex dosage at 10mg/kg). This study is in follow-up to in vivo study results previously announced on April 17, 2018 which utilized a smaller animal population over a 6-hour period.
Key highlights are as follows:
- Peak Level: 79% improvement in peak blood levels (maximum concentration or “Cmax”) at 394 ng/mL using Lexaria’s DehydraTECHTMtechnology vs. 220 ng/mL with the control (95% CI; p=0.0257);
- Total Quantity: 94% improvement in total quantity of nicotine delivered (area under the curve or “AUC”) to the blood during the 60-minute course of the study, at 266 hr•ng/mL versus 137 hr•ng/mL (95% CI; p=0.0086);
- Rapidity: Lexaria’s technology delivered nicotine into the blood stream by the first time interval of blood sampling at the 2-minute mark. On average, Lexaria’s technology delivered 203 ng/mL to the blood in aggregate of the 2, 4, 6, 8, 10, 12 and 15-minute time points, compared to only 120 ng/mL in aggregate over the same period by the control, an improvement of 70% (95% CI; p=0.0004).
A significant amount of data has yet to be received and analyzed from this study, including brain absorption data. The blood plasma data from this nicotine study is considered statistically significant and corroborates and confirms the validity of the results previously announced on April 17, 2018.
|
DehydraTECH™ Formulation (nicotine polacrilex 10 mg/Kg) |
Control Formulation (nicotine polacrilex 10 mg/Kg) |
% Improvement |
pValue |
|
|
Average Nicotine Blood Level 0-15 min (ng/mL) |
203 |
120 |
70 |
0.0004 |
|
Peak Nicotine Blood Level 0-60 min (ng/mL) |
394 |
220 |
79 |
0.0257 |
|
Total Nicotine Absorption (i.e., AUC) 0-60 min (hr?ng/mL) |
266 |
137 |
94 |
0.0086 |
According to the CDC, global deaths from smoking are currently 6 million per year and expected to reach 8 million yearly by 2030. For every fatality from smoking 30 more people live with serious smoking-related illness. (www.cdc.gov/tobacco)
“Lexaria’s DehydraTECH™ breakthrough technology is demonstrating significant effectiveness in delivering nicotine into the bloodstream much more rapidly than we thought possible, and at levels approaching two times more effective than controls,” said Chris Bunka, Chief Executive Officer of Lexaria Bioscience Corp. “If we can develop viable ingestible alternatives to cigarette smoking we could help hundreds of millions of people avoid many of the disease states associated with smoking and I cannot imagine a more rewarding destiny bestowed upon Lexaria Bioscience Corp.”
Lexaria’s in vitro laboratory, in vivo animal and human clinical absorption studies have consistently shown faster delivery and more effective delivery of substances such as nicotine and cannabinoids. Lexaria continues to focus on advancing both its R&D and commercialization initiatives with its DehydraTECHTM technology platform.
About Lexaria
Lexaria Bioscience Corp. has developed and out-licenses its disruptive delivery technology that promotes healthier ingestion methods, lower overall dosing and higher effectiveness of lipophilic active molecules. Lexaria has multiple patents pending in over 40 countries around the world and has patents granted in the USA and in Australia for utilization of its DehydraTECHTM delivery technology. Lexaria’s technology provides increases in intestinal absorption rates; more rapid delivery to the bloodstream; and important taste-masking benefits, for orally administered bioactive molecules including cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), nicotine and other molecules.
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