Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit-O for treatment of opioid use disorder

MELBOURNE, Australia and NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for treatment of Opioid Use Disorder (OUD).

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.

Incannex Chief Scientific Officer Dr Mark Bleackley said: “Opioid use disorder is a significant issue impacting millions of patients and their families. 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. 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.”

About CannQuit-O

CannQuit-O is a chewable tablet with unique characteristics provided by novel combination of registered/FDA-approved polymers allowing for rapid and sustained release of its active ingredients, including an opioid agonist, antagonist and cannabidiol (CBD). The working hypothesis is that the bioavailability profile of the drugs can be significantly improved when formulated as water-soluble, chewable tablet. Incannex owns patents on chewable formulations cannabinoids and opioid agonists and/or antagonists and it is hypothesised that this combination of active pharmaceutical ingredients and delivery system will provide benefits for sufferers of OUD, of which there are estimated 26.8 million people worldwide¹. In the USA the opioid epidemic has been declared a public health emergency, affecting millions with the misuse of prescription opioids and illicit substances. According to the National Institute of Health (NIH), by far the largest components of the overall economic burden, however, are the value of reduced quality of life from opioid use disorder ($390.0 billion) and life lost to opioid overdose ($480.7 billion). These two cost components account for over 85% of the total economic burden².