On May 7, 2024, Incannex Healthcare Inc., a biotechnology company specializing in cannabinoid and psychedelic medicine, announced the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for their product CannQuit-O, aimed at treating Opioid Use Disorder (OUD). The meeting involved discussions with FDA representatives on the clinical development strategy for CannQuit-O, including patient populations, efficacy endpoints, and safety monitoring. The FDA provided recommendations that will guide Incannex in the data required to open an IND with the FDA and ensure successful clinical development. Dr. Mark Bleackley, Incannex's Chief Scientific Officer, emphasized the importance of developing new therapies like CannQuit-O to address the significant impact of OUD...Show More

On May 7, 2024, Incannex Healthcare Inc., a biotechnology company specializing in cannabinoid and psychedelic medicine, announced the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for their product CannQuit-O, aimed at treating Opioid Use Disorder (OUD). The meeting involved discussions with FDA representatives on the clinical development strategy for CannQuit-O, including patient populations, efficacy endpoints, and safety monitoring. The FDA provided recommendations that will guide Incannex in the data required to open an IND with the FDA and ensure successful clinical development. Dr. Mark Bleackley, Incannex's Chief Scientific Officer, emphasized the importance of developing new therapies like CannQuit-O to address the significant impact of OUD on millions of patients and their families. CannQuit-O is a chewable tablet with a unique combination of an opioid agonist, antagonist, and cannabidiol (CBD), designed to improve the bioavailability of the drugs. Incannex holds patents for chewable formulations of cannabinoids and opioid agonists/antagonists. The announcement highlighted the severe economic burden of OUD, with the global market size valued at USD 2.8 billion in 2022 and expected to grow to USD 7.8 billion by 2032. Incannex is pursuing U.S. FDA approval for CannQuit-O, subject to ongoing clinical success, and has a strong patent strategy in place for its product and therapy developments.