- Lexaria Bioscience Corp. expects the upcoming human nicotine study to produce evidence that its patented DehydraTECH(TM) technology can enhance oral-tissue absorption with reduced negative experiences
- Data collected from animal study NIC-A21-1 showed that DehydraTECH enhanced oral nicotine pouches delivered peak nicotine levels in the bloodstream of animals 10x to 20x faster than the control
- The global nicotine pouches market was valued at $2.33 billion in 2020 and is expected to reach $21.84 billion by 2027, being one of the fastest growing segments in the nicotine industry
- Lexaria’s pipeline addresses serious unmet patient or consumer needs with greater market potential, addressing multiple mainstream applications in cannabinoids, oral nicotine, antiviral therapies, phosphodiesterase inhibitors, and other APIs
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently announced the pending start of an upcoming human nicotine study, NIC-H22-1. The company expects to evidence that processing purified nicotine with its patented DehydraTECH(TM) technology leads to enhanced oral-tissue absorption and reduced negative experiences. NIC-H22-1 is a minimum 36-person human pharmacokinetic randomized, double-blind, cross-over study comparing DehydraTECH-nicotine pouch performance to existing brands currently on the market, including ON! and Zyn (https://ibn.fm/aFVPk).
The study’s primary objective is the objective data collection from blood samples that will evidence Tmax, Cmax, and AUC. Other study objectives include extensive subjective evaluations related to complaints of throat burn, user experience, and more. The nicotine test article ingredient manufacturing and DehydraTECH processing have been completed, and the materials have been received by the third-party pouch manufacturing company for filling and packaging. This study’s next two major steps will be Independent Review Board approval and subsequent human dosing.
Through a previous animal study NIC-A21-1, the company has already demonstrated that oral nicotine pouches using DehydraTECH technology were 10x to 20x faster at reaching peak delivery of nicotine to the bloodstream than the control.
Lexaria is leveraging the oral nicotine pouch market, which is one of the fastest growing segments in the nicotine industry due in part to the US Food and Drug Administration’s note of “reduced risk health outcomes” (https://ibn.fm/SmOJi). The delivery method, specifically the white pouch format, avoids harmful lung outcomes experienced by smokers and vapers, only involving absorption primarily through the mouth’s buccal tissues through purified nicotine. In 2020, the global nicotine pouches market was valued at $2.33 billion and is expected to reach $21.84 billion by the end of 2027, growing at a CAGR of 30.7% during the forecast period. (https://ibn.fm/a8Wc0).
On March 8, 2022, Lexaria announced that it had been granted a new patent, “Compositions Infused with Nicotine Compounds and Methods of Use Thereof.” The Australian patent expands Lexaria’s international intellectual property rights to apply DehydraTECH enhancement technology to most oral forms of nicotine, including pills, lozenges, capsules, pouches, gums, and sprays. Lexaria currently has 25 patents granted worldwide plus a 26th patent allowed in Japan.
As detailed in Lexaria’s July 2022 Corporate Presentation, DehydraTECH is faster and more effective at delivering drugs into the bloodstream and brain tissues by increasing bioavailability, improving the speed of onset, reducing drug administrative costs, and masking the unwanted taste (https://ibn.fm/QptMW).
The technology’s pipeline addresses serious unmet patient needs with greater market potential, addressing multiple mainstream applications in cannabinoids, oral nicotine, antiviral therapies, phosphodiesterase inhibitors, and other APIs. The current pipeline includes five studies currently in various stages, including animal PK/PD proof of concept for CBD for epilepsy and PDE5 inhibitors, human PK/PD proof of concept for oral nicotine (NIC-H22-1), and one study currently in the Investigational New Drug (“IND”) enabling study status, DehydraTECH-CBD for hypertension.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX
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