Summary by Moomoo AI
On February 16, 2024, Incannex Healthcare Inc., a biotechnology company specializing in cannabinoid and psychedelic medicine, announced the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for their product CannQuit-N, a novel tobacco smoking cessation solution. The meeting involved discussions on the regulatory aspects of CannQuit-N's development program, with the FDA providing recommendations on clinical trial design, including efficacy and safety endpoints, and confirming the appropriateness of manufacturing and quality control strategies. CannQuit-N is a medicated chewing gum that combines cannabidiol (CBD) with nicotine, aiming to assist smokers in quitting more effectively than traditional nicotine replacement therapies. Incannex holds patents for this combination and anticipates growth in the nicotine replacement therapy market. The company is also developing treatments for various conditions, including obstructive sleep apnoea and traumatic brain injury, with a strong patent strategy and 19 granted patents. This announcement was approved by Incannex's Board of Directors for release to NASDAQ.