- The 36-person human pharmacokinetic randomized, double-blind, cross-over study NIC-H22-1 will compare its patented DehydraTECH(TM)-nicotine to leading nicotine pouches On! and Zyn
- The white pouch oral delivery of nicotine is thought to avoid harmful lung outcomes that smokers and vapers experience
- The global nicotine pouch market was valued at $2.33 billion in 2020 and is expected to reach $21.84 billion by 2027, driven by an increase in the number of consumers seeking alternative forms of nicotine that do not involve lung exposure
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, announced that dosing has commenced for its human clinical nicotine study NIC-H22-1. The study is a 36-person human pharmacokinetic randomized, double-blind, cross-over study conducted on current cigarette smoking subjects. Each participant will visit the laboratory and be dosed three times over the coming weeks. Only one oral nicotine pouch will be administered and evaluated during each visit. Participants will either receive Lexaria’s patented DehydraTECH(TM)-nicotine, On! brand manufactured by Altria, or Zyn brand manufactured by Swedish Match during that time (https://ibn.fm/cz0kO).
The objectives of the NIC-H22-1 study 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. The company also plans to collect subjective evaluations, including throat burn, user experience, gastrointestinal experience, and more.
The global nicotine pouches market was valued at $2.33 billion in 2020 and is expected to reach $21.84 billion by 2027, growing at a CAGR of 30.7% during the forecast period (https://ibn.fm/rhGAj). Key market growth factors include a growing interest in nicotine pouches among those trying to quit smoking and the increased interest of consumers looking for alternative forms of nicotine that do not involve lung exposure.
The oral nicotine pouch category has become one of the fastest-growing segments of the nicotine industry due in part to a 2019 determination by the U.S. Food and Drug Administration (“FDA”) that stated the potential for “reduced risk health outcomes” (https://ibn.fm/CVFzR). The delivery method, in the white pouch format specifically, is thought to avoid harmful lung outcomes experienced by smokers and vapers because it involves absorption primarily through the buccal tissues of the mouth using purified nicotine that has been separated from the other harmful compounds found within the tobacco leaf.
Lexaria’s patented DehydraTECH(TM) technology is designed for formulating and delivering lipophilic (fat-soluble) drugs and active ingredients. DehydraTECH(TM) increases effectiveness and improves how these ingredients enter the bloodstream. Benefits of DehydraTECH include:
- Improved speed of onset, with effects felt in minutes
- Increased bioavailability, with more of the drug delivered into the bloodstream
- Increased brain absorption, with testing suggesting up to 10x improvement
- Improved drug potency, with more of the ingested product made available in the bloodstream requiring lower dosages
Animal studies conducted by Lexaria have demonstrated a propensity for DehydraTECH(TM) technology to elevate the quantity of the drug delivered across the blood-brain barrier by as much as 1,900 percent, which has initiated new patent applications and has opened the possibility of improved drug delivery.
As of September 2022, Lexaria’s development of its patented DehydraTECH(TM) technology since 2014 has yielded over 50 pending patents in countries worldwide, along with 27 granted patents. Lexaria’s focused ongoing research and development efforts span several key segments, including tobacco, nicotine replacement, CBD, cardiovascular drugs, antivirals, epilepsy, human hormones, and PDE5 inhibitors.
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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