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

Incannex Healthcare announced the completion of a pre-IND meeting with the U.S. Food and Drug Administration regarding the development of CannQuit-N for tobacco smoking cessation and control of relapse. The pre-IND teleconference included representatives from various divisions of the FDA covering all regulatory aspects of the CannQuit-N development program. The Agency had reviewed the CannQuit-N meeting package and provided recommendations on key design aspects of the proposed clinical trials, including the timing of efficacy endpoints and specific details on safety endpoints. The FDA also confirmed proposed strategies for manufacturing and quality control are appropriate. The productive discussion with the FDA is an important milestone for the development of CannQuit-N and will guide the continued development of the drug product.