- Lexaria recently reported that dosing of the targeted 36 volunteers in its human clinical oral nicotine study, NIC-H22-1, had been completed
- The company hopes to demonstrate that its DehydraTECH(TM)-processed nicotine absorbs more quickly and more efficiently into the human bloodstream than leading oral nicotine brands
- Through previous animal testing, Lexaria showed that DehydraTECH-nicotine was up to 10x to 20x faster in delivering comparable levels of nicotine and delivered up to 6-fold higher levels of nicotine into blood plasma than concentration-matched controls
- If the findings from the human study replicate a similarly improved performance, Lexaria believes this could facilitate a more satisfying oral nicotine experience than any leading brands sold around the world today
- Success could result in an important commercial relationship developing in 2023, according to CEO Chris Bunka
Lexaria Bioscience (NASDAQ), a global innovator in drug delivery platforms, recently announced that the dosing of the targeted 36 subjects in its human clinical oral nicotine study NIC-H22-1 had been completed. In the meantime, the company has already commenced sample and data analysis and expects to report the findings as soon as possible (https://ibn.fm/7bhFu).
NIC-H22-1 is a human pharmacokinetic randomized, double-blinded, cross-over study that involved 36 human volunteers that are current cigarette smokers. Each participant visited the laboratory for dosing three times over several weeks, and during each visit, only one oral nicotine pouch was administered: Lexaria’s DehydraTECH(TM)-processed purified nicotine, On!(TM) brand manufactured by Altria, or Zyn(TM) brand manufactured by Swedish Match. Dosing began in December 2022 (https://ibn.fm/G4CAT).
“We hope to demonstrate that the Lexaria DehydraTECH-processed nicotine absorbs more quickly and more efficiently into the human bloodstream than the world’s leading oral nicotine brand, Zyn(TM), or America’s third leading brand, On!(TM). If we are successful, we feel this will be a major step towards adoption of our technology into a consumer product, which could result in an important commercial relationship developing in 2023,” Lexaria CEO Chris Bunka wrote in the January 2023 annual letter to stakeholders (https://ibn.fm/3Y7WF).
The study results from years of work as Lexaria sought – and continues to seek – a safe alternative to vaping or cigarette smoking, methods of nicotine intake that pose significant dangers to the health of smokers. Data from the World Health Organization (“WHO”) shows that over seven million people die each year due to direct tobacco use, while about 1.2 million non-smokers die because of exposure to second-hand smoke (https://ibn.fm/OOdMg). And while vapes or e-cigarettes were developed as less harmful alternatives to conventional cigarettes (“c-cigarettes”) because they do not contain combustible tobacco (https://ibn.fm/y5Mj8), NIH-funded studies show that long-term use of e-cigarettes or vaping products can significantly affect the function of blood vessels, increasing the risk of cardiovascular disease (https://ibn.fm/eFnSx).
Over the years, oral nicotine pouches entered the market as companies sought to reduce the societal impact of tobacco globally, and their uptake has been on the up since. According to a 2023 report, the global nicotine pouches market is projected to grow from $4.69 billion in 2022 to $11.91 billion in 2029, representing a CAGR of 13.4% (https://ibn.fm/CR5KW). But despite this projected growth, nicotine pouches have been shown to deliver lower nicotine levels to the blood than with cigarettes, with the time taken to reach peak levels being slower too (https://ibn.fm/ypgdX).
A reluctance by industry to embrace modern technology – has contributed to the failure of older, slow-acting traditional nicotine products to woo smokers; especially considering that in 2020, cigarettes accounted for 84.1% of the retail value sales of all nicotine products, down from 88.9% in 2017 (https://ibn.fm/SyWUk). Given that the global nicotine market is worth roughly $1 Trillion per year, each percentage point of sales represents about $10 billion in revenue. However, Lexaria believes its fast-acting technology – which decreases wait times from as long as an hour to just 3-6 minutes in animal testing – points to a possible seismic shift if improved DehydraTECH nicotine pouches hit the market.
Through animal testing, Lexaria showed that DehydraTECH-nicotine was up to 10x to 20x faster in delivering comparable levels of nicotine into the bloodstream than the peak of concentration-matched controls. The technology also went on to far exceed their total delivery; in particular, it delivered up to 6-fold higher nicotine levels into blood plasma (https://ibn.fm/aSrL6). If the findings from the human study replicate similarly improved performance, Lexaria believes this could facilitate a more satisfying oral nicotine experience than any leading brands sold around the world today.
For more information, visit the company’s website at www.LexariaBioscience.com.
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