Lexaria Bioscience Corporation, a global innovator in drug delivery platforms, announced that on January 29 it has submitted its much-anticipated Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for its planned US phase 1b hypertension clinical trial HYPER-H23-1 of DehydraTECH-CBD.
This IND submission follows a successful pre-IND meeting with the US FDA which provided Lexaria with guidance related to the development and filing of the IND. From 2018 through 2023, Lexaria sponsored five investigator-initiated human clinical studies of its DehydraTECH-CBD in an aggregate total of 134 people, without recording a single serious adverse event (the "Studies"). These Studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens alone and, in some cases, complementary to standard of care medications; suggesting that DehydraTECH-CBD has the potential to have broad therapeutic utility.
As indicated at the FDA website, "once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk."
Lexaria looks forward to commencing clinical trial HYPER-H23-1 as soon as possible following IND effectiveness, subject to certain conditions including funding. The IND review process when successfully concluded will be an important milestone achievement for Lexaria demonstrating that its DehydraTECH technology has met high level formal regulatory scrutiny towards prospective future pharmaceutical commercial registration.
Clinical trial HYPER-H23-1 is entitled ‘A phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension'. The primary objective of the trial will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.
All clinical, laboratory and analysis procedures for study HYPER-H23-1 are to be performed entirely by US-based, third-party independent contract service providers.
DehydraTECH is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 38 patents granted and many patents pending worldwide.
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