Incannex completes pre-IND meeting with FDA for CannQuit-O

Incannex Healthcare announced the completion of a pre-IND meeting with the U.S. Food and Drug Administration regarding the development of CannQuit-O for treatment of Opioid Use Disorder. The pre-IND teleconference included representatives from various divisions of the FDA providing input on the CannQuit-O development program. The Agency had reviewed the CannQuit-O meeting package and provided recommendations on the proposed clinical development strategy, including patient populations, the selection and timing of efficacy endpoints and safety monitoring. These recommendations were discussed during the pre-IND teleconference where the company had the opportunity to seek further clarification on the agency’s initial response. The productive discussion with the FDA is an important milestone for the development of CannQuit-O and provides Incannex with clarity on the data required to open an IND with the FDA for this product and provides valuable guidance for successful clinical development in the OUD indication.