- Lexaria’s successful HYPER-H21-2 human clinical study, whose results were announced in the first week of September 2021, laid the groundwork for the company’s patented DehydraTECH(TM)-processed CBD NDA
- Chris Bunka, the company’s CEO, referred to the results as “statistically significant,” ultimately kickstarting the IND application process with the FDA
- Lexaria has since received a full written positive response from the FDA on its DehydraTECH-CBD, agreeing to the company’s proposal to pursue the 505(b)(2) NDA regulatory pathway
- As a result of the favorable FDA response, Lexaria expects to remain on track to file its full IND application, 6-9 months sooner than if the FDA had required modifications in Lexaria’s current IND-enabling work plan, and Its management is confident that maintaining the current trajectory could allow the company to achieve $1 billion per year in the hypertension market, even making it one of the most effective registered pharmaceutical treatments for hypertension in the world
In the first week of September 2021, Lexaria Bioscience (NASDAQ: LEXX) announced its most recent results, at the time, from its HYPER-H21-2 human clinical study on the overall effectiveness of its patented DehydraTECH(TM)-processed CBD on blood pressure. The successful study would play an integral role in the company’s eventual New Drug Application (“NDA”), with Chris Bunka, the company’s Chief Executive Officer (“CEO”), terming the results as “statistically significant” (https://ibn.fm/iUObW).
The success of multiple human studies investigating DehydraTECH-CBD for hypertension prompted Lexaria to formally announce the process of an Investigational New Drug (“IND”) application filing with the United States Food and Drug Administration (“FDA”) to list DehydraTECH-CBD as a prospective registered pharmaceutical treatment for hypertension.
Lexaria has since received a positive full written response from the FDA regarding DehydraTECH-CBD, with the institution confirming that it agreed to Lexaria’s proposal to pursue a 505(b)(2) NDA regulatory pathway that would hasten the process of commercial approval for its product (https://ibn.fm/cBz7R).
“We are very pleased to have received comments from the FDA toward opening our IND program, and we will be executing FDA-confirmed IND-enabling work immediately,” noted John Docherty, the President of Lexaria.
“We were delighted that our proposals were very well received by the FDA, and the feedback received will be very helpful in compiling and filing our IND application as the new major regulatory step we are focused on moving forward,” he added.
The FDA’s communication also noted that additional non-clinical studies would not be required before initiating the DehydraTECH-CBD IND program, particularly given compelling data already presented by the company and others regarding the safety and tolerability of CBD.
Lexaria is confident that the approval will go through, especially since the FDA already has a history of approving CBD pharmaceutical treatments. In 2018, this approving body gave the green light to Epidiolex(R), a CBD-based pediatric anti-seizure medication. In the approval, they noted that the approved dosage rate for a child weighing 28kg was 140mg, increasing to 280mg daily for long-term use. Lexaria looks to build on this to push for its DehydraTECH-CBD, hoping to offer a viable solution to millions of people living with hypertension.
With the FDA response, Lexaria expects to remain on track to file its complete IND application by late 2022 or early 2023, maintaining the initial targets announced. In addition, given its move to go with the 505(b)(2) pathway as opposed to 505(b)(1), the company looks to shave 6-9 months off of the approval process, bringing its product to the market a lot sooner.
When discussing previous results from the hypertension study, Mr. Bunka noted:
“If we sustain these results, we could be looking at mega-drug status ($1 billion per year) in the hypertension market.”
“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.
This outlook shows Lexaria’s commitment to creating shareholder value, even as it inches closer to offering a viable solution to people living with hypertension. In addition, its commitment to following due process to receive FDA approval reflects the company’s and management’s clear vision and understanding of what it would take to grow the list of product offerings and offer something unique in the market.
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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