New York, New York—(Newsfile Corp. - September 14, 2021) - PCG Digital — The most recent results from HYPER-H21-2, a human clinical study of the effects of Lexaria's DehydraTECHTM-processed CBD on blood pressure (BP) over a 24-hour ambulatory period, have moved the needle significantly in Lexaria's path towards an eventual New Drug Application (NDA). As a precursor to that, the company has begun an Investigational New Drug (IND) enabling program.
Volunteers for HYPER-H21-2 who cope with mild to moderate hypertension averaged up to a 23% decrease in blood pressure, relative to placebo, during the 24-hour period. They also averaged a 7% drop in systolic pressure. The volunteers were administered three doses of 150 mg of DehydraTECH CBD during the 24-hour cycle, spanning both sleep and awake cycles of activity.
The Blood Pressure Study Results are Statistically Significant
"These results are statistically significant," reported Chris Bunka, CEO of Lexaria Bioscience Corp. "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."
Preliminary analysis of the study results shows that each of the three doses resulted in a slightly lower blood pressure level than the trough, which is the lowest concentration reached by a drug before the next dose is administered. This was particularly apparent during the quiet hours of sleep, which is when most cardiac events occur.
IND is the Next Step on the Road to an NDA for DehydraTECH - CBD
Armed with the most recent test results and a history of success with DehydraTECH technology, Lexaria Bioscience Corp (NASDAQ: LEXX) announced last week that it has formally begun the process for an Investigational New Drug application filing with the FDA. The application will list DehydraTECH CBD as a prospective registered pharmaceutical treatment for hypertension.
This is another step to an eventual NDA, provided that ongoing studies continue to show positive results and the company doesn't run into any regulatory hurdles. With both internal and external data on the effectiveness of DehydraTECH, the company may be able to file using the abbreviated 505(b)(2) NDA application, which could significantly speed up timelines.
FDA approval for CBD pharmaceutical treatments is not unprecedented. In 2018, the FDA approved Epidiolex®, a CBD-based pediatric anti-seizure medication. The approved dosage rate for a child weighing 28kg was 140mg, with an increase to 280mg daily for long-term use. DehydraTECH CBD dosages, due to its absorption capabilities, could be significantly less.
DehydraTECH Could Rise to Mega-Drug Status in the BP Space
"If we can sustain these results, we could be looking at mega-drug status ($1 billion per year) in the hypertension market," stated Chris Bunka when asked about projections for the future. "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."
The process ahead will still take several months, but shareholder optimism is high as DehydraTECH CBD continues to be proven effective in multiple applications. Lexaria's commercial success with their technology has already been established. A pharmaceutical breakthrough in the anti-hypertensive space could launch them into unicorn status.
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