- Lexaria’s DehydraTECH-nicotine pouch performance to be compared to existing leading brands ON! and Zyn
KELOWNA, BC / ACCESSWIRE / December 20, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms is pleased to announce that dosing has now begun in its human clinical nicotine study NIC-H22-1.
Study NIC-H22-1 is a 36-person human pharmacokinetic randomized, double blinded, cross-over study conducted in current cigarette smokers, wherein each person will visit the laboratory to be dosed three times over the weeks to come. During each visit only one oral nicotine pouch will be administered and evaluated: either DehydraTECH-nicotine; On! brand manufactured by Altria; or Zyn brand manufactured by Swedish Match.
The primary study objectives are to determine the quantity of nicotine in blood at various time points and vital-sign data collection of temperature, blood pressure, heart rate and respiratory rate. Subjective evaluations related to throat burn, user experience, gastrointestinal experience and more will be conducted.
Nicotine study NIC-H22-1 is fully funded from internal company resources. Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.
The oral nicotine pouch category is of intense interest to Lexaria and is one of the fastest growing segments of the nicotine industry due in part to its reduced risk health outcomes as noted by the Food and Drug Administration (“FDA”). This delivery method, in the white pouch format specifically, which avoids harmful lung outcomes experienced by smokers or vapers, involves absorption primarily through the buccal tissues of the mouth, of purified nicotine that has been separated from most other harmful compounds in the tobacco leaf. The global market for the oral nicotine pouch category was US$2.33 billion in 2020 and is growing at a rapid CAGR of 30.7% and is expected to reach $21.84 billion in 2027.
As reported on March 8, 2022, Lexaria recently received its first ever patent granted to use DehydraTECH to more efficiently deliver nicotine through buccal tissue absorption. Similar patent filings have been made in the USA and in the EU and Lexaria believes those potential patent awards could support significant competitive advantages in the nicotine white pouch category, as well as other oral nicotine product formats.
Separately and as previously disclosed under Item 4.01 of the Company’s Form 8-K as filed with the US Securities and Exchange Commission on November 28, 2022, the Company has appointed MaloneBailey LLP as its new independent auditor. There was no disagreement with the Company’s former auditors, Davidson & Company LLP, related to this change in auditors.
