Lexaria Bioscience submits IND application to FDA for DehydraTECH-CBD trial

Lexaria Bioscience submitted its Investigational New Drug application with the U.S. Food and Drug Administration for its planned U.S. phase 1b hypertension clinical trial HYPER-H23-1 of DehydraTECH-CBD. This IND submission follows a successful pre-IND meeting with the 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. 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.