Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has engaged Eurofins Scientific, a multinational contract development and manufacturing organization, to develop and produce its CannQuit medicated chewable products designed to treat nicotine and opioid addiction disorders.
CannQuit Nicotine (CannQuit-N) and CannQuit Opioid (CannQuit-O) are combination drug assets with granted patents and patent applications that were transferred to Incannex as a result of its acquisition of APIRx Pharmaceuticals in August this year.
“Opioid and nicotine addiction are significant health problems and a major burden on health systems throughout the world,” Incannex chief scientific officer Dr. Mark Bleackley said.
“CannQuit products are designed to improve established therapies for the treatment of addiction. They do this by adding CBD, which is known to reduce cravings and anxiety which is critical for breaking the addiction cycle.”
CannQuit-N comes in the form of a chewing gum to deliver active ingredients directly into the circulation of the oral mucosa. This ensures rapid and sustained delivery to reduce cravings for longer than other delivery methods.
The opioid epidemic has reached critical levels in the US and the industrialized world, according to Incannex. Treatments for opioid use disorder total US$64 billion per annum and there have been no new major treatment solutions in recent decades.
Cigarette smoking, on the other hand, is the leading cause of preventable death in the US, where it is responsible for more than 480,000 deaths per year, including nearly 42,000 deaths from second-hand smoke exposure.
The total cost of smoking in the US is estimated at more than US$300 billion per annum, including 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 to help people quit smoking, but its progression to complete smoking cessation is limited. By adding CBD in a patented combination, CannQuit-N may be able to improve upon the therapeutic outcomes of nicotine-only gum.
“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 theorized enhancements to existing treatment options make us excited to test our hypotheses in clinical trials once the products have been manufactured by Eurofins,” Bleackley said.
Clinical trial candidate
Nicotine replacement therapy by CBD has a solid pre-clinical basis. It has been found to inhibit the α7 nicotinic acetylcholine receptor, which plays a role in the reinforcing effects of nicotine.
Incannex intends to further develop and investigate CannQuit-N in human clinical trials to assess their safety and efficacy in aiding smoking cessation and for the treatment of opioid addiction.
Data collected during their development and manufacturing at Eurofins will be key components of future filings with the US Food and Drug Administration (FDA), including for investigational new drug (IND) applications and new drug applications (NDA).