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…