- Lexaria is a global innovator in drug delivery platforms developing DehydraTECH-CBD as a potential treatment for hypertension
- A 2022 study documented a decline in the percentage of patients receiving appropriate treatment intensification over the last ten years
- This decline has been attributed to, among other possible reasons, the side effects of antihypertensive drugs
- At the same time, only 24% of adults with hypertension have the condition under control, a statistic attributable to the medications’ troublesome side effects
- Lexaria’s investigations of its DehydraTECH-CBD have so far presented favorable safety and tolerability data, meaning its drug candidate could offer reprieve to millions looking for antihypertensive drugs with little or no side effects
A recent study published in the American Heart Association (“AHA”) journal Hypertension concluded that “appropriate treatment intensification for older adults with hypertension in the United States was suboptimal over the past decade” (https://ibn.fm/yplwP). The study results showed the percentage of patients receiving appropriate treatment intensification – described as the addition of an antihypertensive drug to the patient’s care for high blood pressure – had declined over the ten years across all the three blood pressure targets used.
The study sampled adults aged 60 and older who visited their primary care provider and previously had been diagnosed with hypertension, with the researchers focusing on patients that had undergone appropriate antihypertensive intensification.
Although the study did not discuss the reasons behind the decline, a recent article analyzing the findings (https://ibn.fm/tjFIr) highlighted several theories that the study’s senior author Dr. Kenneth Mukamal offered. Per Dr. Mukamal, the decline might have resulted from “doctors’ concerns that blood pressure-lowering drugs might cause older adults to fall, patients’ reluctance to add more medications that might have more side effects, [and the difficulty faced by] primary care providers to treat high blood pressure aggressively in a typical 15-minute visit.”
Dr. Mukamal’s theories document an existing concern. According to the U.S. Center for Disease Control (“CDC”), only about 24% of adults with hypertension have the condition under control (https://ibn.fm/g3qjt). A commonly cited reason for this low statistic is that patients stop taking their medication largely because of troublesome side effects. Even so, a solution, which is being developed for patients with hypertension by drug delivery platforms innovator Lexaria Bioscience (NASDAQ: LEXX), may be on the horizon (https://ibn.fm/rUOYQ).
Packaged in the form of enhanced cannabidiol (“CBD”), whose bioavailability properties have been improved by the company’s patented DehydraTECH(TM) drug delivery technology, the solution, known simply as DehydraTECH-CBD, may potentially address the low antihypertensive intensification as well as the relatively high prescription abandonment rates for hypertension drugs.
DehydraTECH-CBD has so far undergone animal and human studies as part of preliminary investigations designed to provide crucial data that would back Lexaria’s pursuit of registration for Phase Ib clinical trials. The preliminary research showed that DehydraTECH delivered 317% more CBD to the blood 30 minutes after ingestion, a remarkable improvement considering the oral bioavailability of CBD is estimated at 6% (https://ibn.fm/HYDPx).
Further human studies showed that DehydraTECH-CBD resulted in a rapid and prolonged drop in blood pressure, reduced arterial stiffness, and attenuated pulmonary artery systolic pressure. Generally, the studies yielded compelling CBD safety and tolerability data that were further reinforced by the company’s fourth human study, HYPER-H21-4, whose dosing Lexaria completed this summer. (Studies are available at https://ibn.fm/3DuBG, https://ibn.fm/mF15O, and https://ibn.fm/TUMYz.
“We are extremely pleased that dosing has been completed on time in this multiweek clinical study without any adverse events having occurred,” said Lexaria CEO Chris Bunka of the fourth human study. “Demonstrating a noteworthy safety and tolerability profile relative to conventional antihypertensive medications is one of Lexaria’s major goals with this program, and avoiding serious adverse events at clinically efficacious doses will be a primary requirement to achieve eventual regulatory marketing authorizations.”
Although CBD is usually well tolerated, it could cause liver toxicity in the high therapeutic doses required to treat conditions such as epilepsy or hypertension. Currently, there is only one FDA-approved CBD therapeutic, branded Epidiolex, used to treat seizures at a maximum approved dose of up to 10 mg per kilogram of body weight, given twice a day. But Lexaria believes DehydraTECH’s ability to increase CBD’s bioavailability could reduce the dose prescribed to patients (https://ibn.fm/WcfHe).
With an eye on potentially delivering the second-ever FDA-approved CBD drug, Lexaria is working with the FDA to commence registered clinical trials and is on course to file an Investigational New Drug (“IND”) application in late 2022 or early 2023.
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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