Clinical-stage pharmaceutical company Incannex Healthcare (ASX: IHL) has engaged French organisation Eurofins Scientific to manufacture its medicated chewable products designed to treat nicotine and opioid addiction disorders.
Marketed under the CannQuit label, the combination drug assets have associated granted patents and applications which were transferred to Incannex when it acquired APIRx Pharmaceuticals in August.
CannQuit Nicotine combines nicotine and cannabidiol (or CBD) within a medicated chewing gum.
CannQuit Opioid combines CBD and an off-patent prescription opioid antagonist, also within a medicated gum.
The products will be manufactured by Eurofins and used in clinical trials to assess the safety and efficacy of the CannQuit range for smoking cessation and the treatment of opioid addiction.
Data collected on the quality and stability of each product during development and manufacturing will be key components of future regulatory packages including with the US Food and Drug Administration.
Established therapies
Incannex chief scientific officer Dr Mark Bleackley said the CannQuit anti-addiction range is designed to work alongside established therapies.
“Opioid and nicotine addiction are a major burden on health systems throughout the world,” he said.
“CannQuit products are designed to improve established therapies for the treatment of addictions by adding CBD to reduce cravings and anxiety, which are critical [components] for breaking the addiction cycle.”
Rapid and sustained delivery
Medicated chewing gums deliver active ingredients directly into the oral mucosa, ensuring the effects are delivered rapidly and in a sustained manner to reduce cravings.
CBD and the act of chewing have both been shown to help stress and anxiety reduction in people with addictions.
“We believe 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,” he said.
“We are excited to test the theories in clinical trials once the products have been manufactured by Eurofins.”
Leading cause of death
Cigarette smoking remains a leading cause of preventable death in the US, with a total economic cost of more than US$300 billion per annum.
This includes nearly US$170 billion in direct medical care for addicted adults and more than US$156 billion in lost productivity.
While nicotine chewing gum has become an accepted product worldwide, it has limited success in helping people completely stop the habit.
By adding CBD in a patented combination, CannQuit-N is expected to improve the therapeutic outcomes of nicotine-only gum.
“Nicotine replacement therapy by CBD has a solid pre-clinical basis which encourages [us] to further develop and investigate CannQuit-N in human clinical trials,” Dr Bleackley said.
Opioid epidemic
The opioid epidemic is reported to have reached critical levels in the US.
Statistics show that fatal overdoses and opioid use disorder cost the nation more than US$1 trillion in 2017.
Treatments for opioid use disorder total US$64 billion per annum and there have been no major new treatment solutions in recent decades.
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