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Lexaria Bioscience Corp. (NASDAQ: LEXX) Draws Closer to NDA Filing for DehydraTECH CBD
September 17, 2021

Lexaria Bioscience Corp. (NASDAQ: LEXX) Draws Closer to NDA Filing for DehydraTECH CBD

  • Lexaria just released the most important results yet from its ongoing HYPER-H21-2 human clinical trials on the effects of the company’s patented DehydraTECH(TM)-processed CBD on blood pressure
  • Chris Bunka, Lexaria’s CEO, termed the results as “statistically significant”
  • Participants in the study reported up to an average 23% decrease in blood pressure and a 7% drop in systolic pressure
  • These results bring Lexaria closer to NDA filing with the FDA, making it a pioneer in CBD hypertension treatment 

Lexaria Bioscience (NASDAQ: LEXX) just released the most recent results from its ongoing HYPER-H21-2 human clinical trials on the effects of the company’s patented DehydraTECH(TM)-processed CBD on blood pressure (“BP”) over a 24-hour ambulatory period. The results, referred to as “Statistically significant” by Chris Bunka, the Chief Executive Officer (“CEO”) of Lexaria, inched the company closer to an eventual New Drug Application (“NDA”) (https://ibn.fm/pDUHy). 

The study involved volunteers getting three doses of 150 mg of DehydraTECH CBD over 24 hours, spanning both sleep and wake cycles of activity. Participants coping with mild to moderate hypertension reported up to an impressive average 23% decrease in blood pressure, relative to placebo, during the 24 hours. The study also showed that these individuals averaged a 7% drop in systolic pressure.

Upon further analysis of the results, it was established that each of the three doses resulted in a slightly lower blood pressure level than the trough, which is usually the lowest concentration reached by a drug before the next dose is administered. This was mainly apparent during the quiet hours of sleep when most individuals are more prone to cardiac events.

When making the announcement, Mr. Bunka noted:

“Our 2018 study showed a slight reduction in blood pressure, but it was not awe-inspiring. This time, the average drop in blood pressure is larger, and it appears that the sequential doses are additive. We’ll investigate that further.”

This clinical trial and the results from the study so far have prompted Lexaria into beginning an Investigational New Drug Application (“NDA”) filing with the FDA. The company plans to make the application, listing DehydraTECH CBD as a prospective registered pharmaceutical treatment for hypertension. DehydraTECH CBD is already patent granted in both the EU and in Australia, for treating heart disease.

Going forward, Lexaria expects to stay consistent with its studies, with the hope of showing more positive results. The goal is to leverage both internal and external data on the effectiveness of DehydraTECH and even to possibly use the abbreviated 505(b)(2) NDA application to speed up timelines for approval.

“If we can sustain these results, we could be looking at mega-drug status ($1 billion per year) in the hypertension market,” noted Mr. Bunka. “Our goal now is to put together a 4-week study, three doses per day, targeting a sustained drop in blood pressure. That could make us one of the most effective registered pharmaceutical treatments for hypertension in the world, with few if any unwanted side effects,” he added.

Lexaria is currently focusing on undertaking the requisite procedures, having already established commercial success with its technology. Shareholders are optimistic about the company’s future, and for a good reason. The strides that Lexaria has made so far have brought it even closer to its DehydraTECH approval for hypertension treatment and management.

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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