FDA Experts Weigh In On Incannex's CannQuit-O With Feedback On CBD As Treatment For Opioid Use Disorder

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 of its active ingredients.

The Melbourne, Australia-based company has engaged multinational contract development and manufacturing organization Eurofins Scientific ERFSF to manufacture Incannex's two distinct medicated chewable products designed to treat opioid addiction and nicotine disorders in 2022.

On Monday, Incannex officials said discussion with the FDA provided it with clarity on the data required to open an IND with the FDA for this product while providing valuable guidance for successful clinical development in the OUD indication.

"Developing new therapies, such as CannQuit-O, is critical for helping control the disease and improve quality of life for those who are suffering from the disease and those around them," said Incannex chief scientific officer Dr Mark Bleackley. "Feedback from the FDA on the proposed development strategy for CannQuit-O will be taken on board so that the outcomes of research activities meet agency expectations and ensure that the appropriate steps are being taken towards drug registration."

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IXHL Price Action

Incannex Healthcare's shares traded 9.09% higher at $2.52 per share at the time of writing on Tuesday.