Incannex Healthcare Inc. (NASDAQ:IXHL), a cannabinoid and psychedelic medicine biotechnology company, announced the successful completion of a pre-investigational new drug meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for the treatment of opioid use disorder (OUD).
A number of FDA representatives shared insights on the CannQuit-O development program during the pre-IND teleconference in addition to providing recommendations on the proposed clinical development strategy.
CannQuit-O combines CBD and an off-patent prescription opioid antagonist, and/or partial agonist-antagonist within the formulation. It's a chewable tablet with unique characteristics provided by a novel combination of registered/FDA-approved polymers allowing for rapid and sustained release ...