Clinical-stage pharmaceutical company Incannex Healthcare Limited (ASX: IHL) has engaged multinational contract development and manufacturing organisation (CDMO) Eurofins Scientific to manufacture its two distinct medicated chewable products designed to treat nicotine and opioid addiction disorders.
The CannQuit products are combination drug assets with associated granted patents and patent applications that were transferred to Incannex as a result of the acquisition of APIRx Pharmaceuticals, completed in August of 2022. Eurofins will undertake formulation development and manufacture of CannQuit Nicotine and CannQuit Opioid.
CannQuit-N combines nicotine and cannabidiol (CBD) within a controlled-release, functional, medicated chewing gum. CannQuit-O combines CBD and an off-patent prescription opioid antagonist, and/or partial agonist-antagonist within the formulation. The cGMP grade products manufactured by Eurofins will be used in clinical trials designed to assess the safety and efficacy of the CannQuit products for smoking cessation and the treatment of opioid addiction.
Data collected on the quality and stability of the CannQuit anti-addiction products during the development and manufacturing of the two drug candidates at Eurofins will be key components of future regulatory packages. These data packages include investigational new drug (IND) applications and new drug application (NDA) filings with the US Food and Drug Administration (FDA).
Medicated chewing gums deliver their active ingredients directly into the circulation of the oral mucosa, ensuring that the effects of the ingredients are delivered rapidly, but also in a sustained manner to reduce cravings for longer than other delivery methods. Rapid onset and sustained effect are both qualities desirable for the treatment of addiction disorders. Furthermore, the act of chewing, known as mastication, also has an multi-action, anti-anxiety effect that has been demonstrated in other scientific assessments.
Opioid and nicotine addiction are significant health problems and a major burden on health systems throughout the world. CannQuit products are designed to improve established therapies for the treatment of addiction,” Dr Mark Bleackley, chief scientific officer of Incannex, said.
“They do this by adding CBD, which is known to reduce cravings and anxiety which is critical for breaking the addiction cycle”.
“In the case of CannQuit-O, we add CBD and the act of chewing to a well-established opioid antagonist and/ or agonist/ antagonist therapy. Both CBD and the act of chewing, are conducive to stress and anxiety reduction.
“We believe that the synergies between the pharmaceutical ingredients and the form of the product, as a sustained chewable, gives CannQuit strong potential to improve treatment outcomes for people who are addicted to nicotine and opioids. These theorised enhancements to existing treatment options make us excited to test our hypotheses in clinical trials once the products have been manufactured by Eurofins”.
US Opioid Epidemic
The opioid epidemic has reached critical levels in the United States and the industrialized world. Fatal opioid overdoses and opioid use disorder cost the United States $1.02 trillion in 2017, as measured by the Centre for Disease Control (CDC) in the journal Drug and Alcohol Dependence, which is the most complete accounting of America’s opioid crisis to date. Treatments for opioid use disorder total US$64B per annum and there have been no major new treatment solutions in recent decades.
Cigarette Smoking and Nicotine Addiction
Cigarette smoking causes a wide variety of preventable diseases and remains a leading cause of preventable death in the United States, where it is responsible for more than 480,000 deaths per year, including nearly 42,000 deaths from second-hand smoke exposure. The total economic cost of smoking in the US is estimated at more than US$300 billion per annum. This includes nearly US$170 billion in direct medical care for adults and more than $156 billion in lost productivity.
Nicotine chewing gum is already a long-standing and accepted product throughout the globe with annual sales amounting to $US5.2B in 2020, however, the progression to complete smoking cessation is limited.
By adding CBD in a patented combination, CannQuit-N is hypothesised by Incannex to improve upon the therapeutic outcomes of nicotine only gum. The patented technology of controlled and sustained release of the active ingredients also is believed to improve the therapeutic value of this novel drug candidate.
Nicotine replacement therapy by CBD has a solid pre-clinical basis and encourages Incannex to further develop and investigate CannQuit-N in human clinical trials. CBD has been found to inhibit the α7 nicotinic acetylcholine receptor which plays a role in the reinforcing effects of nicotine. Interactions of endocannabinoids with the CB1 receptor are essential in mediating behaviours associated with addiction and there are preliminary clinical observations suggesting that CBD may help to reduce the number of cigarettes smoked in a day.