Lexarias Human Nicotine Study Nearing Start Date
2022-07-13 09:06 ET - News Release
(via TheNewswire)
Lexaria is targeting the oral nicotine pouch category, one of the fastest growing segments of the nicotine industry.
Kelowna, British Columbia - TheNewswire - July 13, 2022 - Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the pending start of its upcoming human nicotine study NIC-H22-1. Lexaria expects to evidence that processing purified nicotine with its patented drug delivery technology, DehydraTECH TM , leads to enhanced oral-tissue absorption and reduced negative experiences.
Study NIC-H22-1 is a minimum 36-person human pharmacokinetic ("PK") randomized, double blinded, cross-over study to compare Lexaria's DehydraTECH-nicotine pouch performance to that of existing leading brands currently sold in the US such as ON! and Zyn . Objective data collection from blood samples that will evidence Tmax , Cmax , and AUC is the primary objective of the study. Secondary objectives include extensive subjective evaluations related to throat burn, user experience, and more.
The nicotine test article ingredient manufacturing and DehydraTECH processing have been completed and those processed materials have been received by the third-party pouch manufacturing company for filling and packaging. Independent Review Board approval and subsequent human dosing will be the next two major steps in this study.
A s reported on March 8, 2022 , Lexaria received its first ever patent granted to use DehydraTECH to more efficiently deliver nicotine through buccal tissue absorption, in Australia. A similar patent filing has been made in the USA and Lexaria believes that potential patent award could support significant competitive advantages in the nicotine white pouch category, as well as other oral nicotine product formats such as pills, tablets, lozenges, capsules, gums and sprays.
The oral nicotine pouch category 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.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH(TM), improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com .
