- Lexaria has begun the formal process of preparing an application for Investigational New Drug status for DehydraTECH(TM) and cannabidiol for hypertension
- The filing is being done with the assistance of an outside consultancy group, with Lexaria Bioscience designing non-clinical, clinical, and related product development required prior to the filing – all of which support Lexaria’s more ambitious goals
- There have been two successful human hypertension trials done with the combination DehydraTECH-CBD therapy in 2021, following an original human clinical study in 2018, and many animal studies
- Lexaria is making a strong case to support the efficacy of the technology for treating hypertension
Lexaria Bioscience (NASDAQ: LEXX), a global innovator currently enhancing the speed and efficiency of orally-delivered fat-soluble active molecules and drugs, is announcing that it has begun the formal process of preparing for Investigational New Drug (“IND”) certification with the US Food and Drug Administration (“FDA”). The IND will be for the company’s patented DehydraTECH-processed cannabidiol (“CBD”) as a prospective registered pharmaceutical treatment for high blood pressure (hypertension) (https://cnw.fm/gv5bN).
With the help of an expert regulatory affairs and quality assurance consultancy group, Lexaria has begun preparations for a pre-IND meeting with the FDA and designing the non-clinical, clinical, and related product development IND-enabling work that must be completed prior to the IND filing. The IND-enabling program is being made possible by successfully completing studies supporting the company’s more ambitious goals.
The company recently achieved results from two successful human clinical pharmacodynamic hypertension studies done in 2021. In addition to the human pharmacokinetic study in 2018 and successful animal studies proving the performance and molecular characterization work through Canada’s National Research Council, Lexaria provides a strong case with supporting bodies of evidence for the DehydraTECH-CBD combination. The studies have shown that DehydraTECH-CBD provides superior bioabsorption upon administration orally and the efficacy of reducing blood pressure without the presence of significant side effects.
The IND application is also expected to use data from the company’s third and fourth 2021 human clinical hypertension studies. Lexaria hopes to contribute further data to the growing package of information. Provided that the studies continue with favorable outcomes, the company plans to file the IND at the appropriate time and possibly through an abbreviated 505(b)(2) pathway.
Lexaria specifically designed DehydraTECH to formulate and deliver lipophilic (fat-soluble) drugs and other active ingredients. The major benefits assigned to ingesting a DehydraTECH-enabled drug includes:
- Speeding up the delivery of the drug – effects may be felt in a matter of minutes
- An increase in bioavailability – more effective at delivering compounds into the bloodstream
- An increase in brain absorption – animal testing has suggested a significant improvement in the quantity of the DehydraTECH-enabled drug across the blood-brain barrier
- Increased potency – more of the ingested product is made available to the body requiring lower doses to be administered
- Lower drug administration costs – lower dosages equate to lower administration costs
- Covering up the unfavorable taste – the technology eliminates or reduces the need for additional sweeteners
Through animal studies, Lexaria has demonstrated that the quantity of DehydraTECH-enabled drugs across the blood-brain barrier is elevated to as much as 1,900 percent. This finding has enabled the company to initiate new patent applications and opens possibilities for improved drug delivery across the board.
Lexaria began developing DehydraTECH in 2014 and has since been working through a collective research agreement with the National Research Council. DehydraTECH is suitable for use with a wide range of product formats, including pharmaceuticals, nutraceuticals, consumer packaged goods, and over-the-counter capsules, pills, tablets, and oral suspension. Protective patents have been filed for specific delivery of nicotine, vitamins, NSAIDs, testosterone, estrogen, cannabinoids, terpenes, PDE5 inhibitors (brand names like Viagra), tobacco, and more.
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://cnw.fm/LEXX
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