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Across Australia, pharmaceutical companies are undergoing rigorous clinical trials to gain regulatory approval for their cannabinoid products. Following some promising results, over-the-counter products could be hitting the shelves sooner than previously thought.
For thousands of years, the cannabis plant has been recognised for its medicinal attributes. Dating as far back as 2800 BC, cannabis was employed in the treatment of diverse health conditions and was included in Emperor Shen Nung’s ancient pharmacopoeia.
Nung is considered the father of Chinese medicine and is believed to have invented the treatment of acupuncture. But cannabis hasn’t been without its controversies and throughout much of the 1900s was largely demonised and as a consequence out of favour for medicinal use.
However, the stigma associated with cannabis-based medicine and health products is well and truly abating. In light of the increasing global recognition of medicinal cannabinoids, Australia’s Therapeutic Goods Administration (TGA) reclassified low-dose cannabidiol (CBD) from a prescription medication (Schedule 4) to a pharmacist-only medicine (Schedule 3).
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The decision enabled TGA-approved low-dose CBD-containing products included on the Australian Register of Therapeutic Goods (ARTG) for use in adults, to be supplied over-the-counter (OTC) by a pharmacist, without a prescription from February 2021.
It all sounded good in theory for cannabinoid products to be sold OTC as long as they’re below the allowed dosage of 150mg/day and included on the ARTG but in practice it hasn’t worked out that way…well yet anyway.
You see, there are currently no TGA cannabinoid-approved products on the ARTG that meet the Schedule 3 criteria.
The criteria explained
The TGA’s requirement for all Schedule 3 cannabinoid medications to be included on ARTG has faced criticism given that proving efficacy is a primary prerequisite, which predominantly requires arduous, expensive and time-consuming clinical trials.
Trials are generally divided into three phases with Phase 1 focusing on safety, Phase 2 testing for effectiveness and Phase 3 examining whether the new drug is an improvement on existing treatment.
Medicines not included in the ARTG are known as unapproved medicines and according to the TGA have not been evaluated by the authority for quality, safety and effectiveness. Unapproved CBD medicines can continue to be accessed via the Special Access Scheme (SAS) or Authorised Prescriber (AP) scheme on prescription only.
In terms of cannabis companies providing medicinal cannabis products under the SAS or AP scheme, the list is long.
Some frontrunners for OTC development
Bod Australia is in pole position to have the first Schedule 3 CBD product in the Australian market after earlier this month announcing positive preliminary results from its Phase 2B Can-Rest Insomnia trial.
“The trial completion marks a significant breakthrough for Bod for our uniquely formulated Schedule 3 CBD product,” shares CEO Jo Patterson. “The singularity of this product is in its soft gel format, utilising a patent-protected encapsulation technology.”
Neurotech’s proprietary broad-spectrum cannabinoid drug therapy NTI164 is currently being investigated across three clinical trials in paediatric patients suffering from autism, Rett Syndrome and PANDAS/PANS, which are neurological disorders characterised by elevated neuroinflammatory processes.
“We are developing NTI164 as a therapy for predominately rare paediatric neurological disorders, where safe and effective therapies are lacking,” says executive director Dr Thomas Duthy
The European-based company has conducted and finished several trials of its medicinal products. Furthermore, the company has had several research papers published with leading institutions including RMIT on The Pathophysiology and the Therapeutic Potential of Cannabinoids in Prostate Cancer.
Zelira successfully completed an IRB-approved, multi-arm head-to-head study of its proprietary diabetic nerve pain drug ZLT-L-007 against Pfizer’s multi-billion-dollar annual revenue drug Lyrica. ZLD now plans to progress their cannabinoid-based oral capsule into further formal clinical trials on a path towards regulatory approval.
Incannex Healthcare has the world’s largest portfolio of patented medicinal cannabinoid drug formulations and psychedelic treatment protocols. They have an upcoming pivotal (Phase 2/3) study of its novel cannabinoid combination for patients with obstructive sleep apnoea after promising Phase 2 results were released last year.
“We also have other early-stage cannabinoid assets which we plan to take to trial in the future,” CEO Joel Latham told Stockhead. “We see ourselves as a fully-fledged biotech so we want to develop novel treatments with are clinically and scientifically validated to achieve registration with the major health regulators globally.”
The original version of this article was published on stockhead.com.au and has been republished with permission.
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