Lexaria Bioscience Corp 8-K, filed Aug 15, 2022
Lexaria Bioscience Corp. (LEXX)
About this 8-K
Lexaria Bioscience Corp filed this 8-K on August 15, 2022, reporting on events of August 10, 2022.
Items reported
- Item 8.01: Other events
UNITED STATES
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CURRENT REPORT
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Item 8.01 Other Events
Investigational New Drug (“IND”) Application Progress
Lexaria Bioscience Corp. (“Lexaria”) received a positive full written response from the Food and Drug Administration (“FDA”) from its pre-Investigational New Drug (“Pre-IND”) meeting regarding DehydraTECH-CBD for the treatment of hypertension.
The FDA confirmed that it agreed with Lexaria’s proposal to pursue a 505(b)(2) new drug application (“NDA”) regulatory pathway for its program which is advantageous because this abbreviated pathway, as it is often described, typically enables a faster route to commercial approval than the traditional 505(b)(1) NDA pathway.
Lexaria’s proposed Phase Ib clinical protocol for DehydraTECH-CBD for treatment of a target of 100 patients with hypertension was received favorably by the FDA, with a view to opening the IND application to allow Lexaria to work towards full registration of DehydraTECH-CBD for treatment of hypertension.
In addition, the FDA agreed that additional non-clinical studies were not required prior to initiation of the DehydraTECH-CBD IND program, given the compelling data already presented by Lexaria and others regarding the safety and tolerability of CBD.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
LEXARIA BIOSCIENCE CORP. |
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/s/ Chris Bunka |
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Chris Bunka |
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CEO, Principal Executive Officer |
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Date: August 15, 2022 |
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