- Clinical study HYPER-H21-1 evaluates the use of patented DehydraTECH(TM)-processed CBD for use against hypertension
- Hypertension is a primary or contributing factor in the death of almost 500,000 people per year, with approximately one in four adults aged 20 to 44 suffering from high blood pressure
- Initial results of the study show that blood pressure was reduced in both male and female volunteers, resulting in the reinforcement of pre-existing findings demonstrating that DehydraTECH delivers superior performance
- Lexaria plans on launching two additional clinical trials, for a total of three clinical trials in 2021 for the DehydraTECH-CBD with hypertension applications
Lexaria (NASDAQ: LEXX), a global innovator of proprietary patented drug delivery platform DehydraTECH(TM), has released partial results from human clinical study HYPER-H21-1. The study evaluates DehydraTECH-processed cannabidiol (“CBD”) for potential application against hypertension (https://nnw.fm/6RXlk).
Hypertension, also referred to as high blood pressure, is a primary or contributing factor in the deaths of almost 500,000 people per year. Hypertension can double the risk of having a heart attack or quadruple the chance of having a stroke. The likelihood of heart failure, vision loss, renal disease, peripheral artery disease, dementia, and more can be attributed to cases of high blood pressure. Statistically, one in four adults aged 20 to 44 has high blood pressure.
The partial results showed that blood pressure was reduced across both male and female volunteers; it was most pronounced with DehydraTECH-CBD in the study’s first 10 to 50 minutes. These results reinforced the pre-existing findings demonstrating that DehydraTECH delivers superior performance over generic CBD controls.
Chris Bunka, CEO of Lexaria, commented on the study, saying, “We are very encouraged by these early results in our 2021 hypertension program. Lexaria’s technology enabled a rapid and sustained drop in blood pressure, especially systolic pressure and particularly in Stage 2 hypertensive volunteers.”
Lexaria’s DehydraTECH technology is designed for formulating and delivering lipophilic (fat-soluble) drugs and active ingredients. The method increases the effectiveness and improves the way that active pharmaceutical ingredients enter the bloodstream (like CBD). Benefits of the delivery method include:
- Quicker delivery
- Increase in bioavailability
- Increase in the brain absorption
- Improved drug potency
- Reduced drug administration cost
- Masked unwanted taste
Lexaria has demonstrated these benefits from other animal studies, elevating the quantity of the drug delivered across the blood-brain barrier by as much as 1,900%.
Lexaria was also pleased that the subjects of this human clinical study tolerated the DehydraTECH-CBD, with no serious adverse events or side effects observed or reported. The concentration-matched, generic CBD control ingested resulted in unwanted side effects in some volunteers — primarily gastrointestinal problems, including diarrhea.
Lexaria plans to complete its ongoing additional sample and data analyses work for this study, reporting upon those outcomes when complete. A second human clinical hypertension study, HYPER-H21-2, has completed dosing, with three different doses of DehydraTECH-CBD (150mg per dose), administered evenly over the course of a 24-hour monitoring period.
The company is optimistic that repeated dosing over this sustained period may further enhance efficacy. The results of both studies will be evaluated and considered before the company begins its planned third human clinical hypertension study planned for fall 2021. Lexaria is considering evaluations for a fourth, expanded, randomized, controlled human clinical hypertension trial. The fourth trial will be dependent on the results from the current trials and investigations into a larger population for a more enhanced statistical and clinical significance.
For more information, visit the company’s website at www.LexariaBioscience.com.
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