These are exciting times for the growing and evolving cannabis industry. Canada is on the way towards full legalization (mid-Oct), and agricultural, processing, testing, and manufacturing ventures are poised to hit it big. Other countries such as Uruguay have passed full legalization, while others like the US have inched closer – state by state.
What does this bounty of progress mean for the medicinal marijuana field? Quite possibly the advent and proliferation of breakthrough therapeutics to ease the suffering of patients seeking alternatives to conventional drugs and those of which symptoms have remained intractable to therapies thus far.
Progress along these fronts also means validation of tools and techniques necessary for pharmaceutical grade cannabis-derived drug production. Product innovations and standardization continue to advance as well. These are important times in the unlocking of cannabis therapeutic potential – and valuable times for those investing in this exploding industry.
FDA Approval of the Pharmaceutical-Grade CBD Drug Epidiolex
An FDA advisory panel recently recommended Edipiolex for FDA approval -- which was officially granted on June 25 thereby elevating this first in class cannabis-derived CBD drug to prescription-medicine status. The implications for patients suffering from Dravet and Lennox-Gastaut Syndromes, two conditions involving epileptic seizures for which few or no drugs are available, are critical.
A statement from the FDA commissioner detailed the proper evaluation, production, clinical trails, and safety measures that were taken in reaching this approval. The achievement will likely open the door to FDA approval of additional therapeutics – provided development is based on well founded and careful clinical investigation.
The approval also underscores the production of pharmaceutical-grade CBD derived directly from cannabis – a healthy dose of validation for the equipment, methods, and practices needed to get to this point.
This is truly a victory for the agricultural methods, harvesting and processing equipment, extraction and purification technologies, testing and production GLP and GMP practices – those that will see expanded use and modifications as production of Epidiolex scales-up.
The Current Legal Status of Hemp
The chicken or the the egg – cannabis style. Hemp is a close blood cousin of Cannabis sativa. It is in fact a cannabis strain that has been cultivated in a tangential manner over thousands of years to produce the tough fibrous stalky plant observed today. Hemp is rich in cannabinoids including it’s most abundant, cannabidiol (CBD), although it is lacking other cannabinoids and is largely absent THC.
The many industrial uses and medicinal value of hemp have been touted religiously. Some might ask why does hemp remain illegal at the federal level? The backstory of hemp legality is rich and sticky and, save for time, let’s just say that hemp needed a spark -- one it certainly received with the FDA approval of the hemp-derived CBD drug Epidiolex.
Perhaps not by coincidence, the US senate recently voted in favor of hemp legalization at the federal level. Beyond legalization the next step may possibly be the delisting of CBD as a Schedule 1 controlled substance – a category shared by THC, cocaine, heroine, and other illicit drugs. In order for CBD drugs like Epidiolex to be “legally” prescribed, federal delisting by the DEA is a necessary step.
The Cannabis Therapeutic Pipeline
Beyond the established merits of cannabis for the treatment of nausea, appetite stimulation, pain relief, and epilepsy, many more claims exist regarding cannabis as a *de facto* miracle drug for maladies ranging from anxiety to cancer. The pipeline of potential therapeutics is rich with promising yet often unsubstantiated effects, owing in part to the void in basic research. Opening the door for FDA approval – as in the case of Epidiolex – sets an important precedent that careful clinical studies and trails, when conducted under the auspices of FDA regulations, may in fact lead to medically sound cannabis-based therapeutics, despite the lack in underpinning research.
Where cannabis has proven vital in palliative care of cancer-related side effects, the potential for cannabis as adjunctive treatments during chemotherapy may as well prove useful. Studies are amassing regarding the use of cannabis for cancer treatment – is this a sign of things to come?
Classification of cannabis as a Schedule 1 controlled substance has restricted the amount and type of basic scientific research that can be conducted. These barriers to research persist at a time when more information than ever is needed regarding the long-term effects, efficacy, and side effects of cannabis-related compounds. It stands in the face of reason to ease restrictions on public consumption while limiting medical research – something that de-scheduling CBD and other medically relevant cannabinoids would certainly address.
Beyond US states establishing medical research councils and initiatives on the heels of medical cannabis legalization, some other countries have made significant progress in lowering the research barrier in a more dramatic way. Canada teeters on complete legalization, and the Canadian Institutes of Health Research (CIHR) – similar to the National Institutes of Health (NIH) in the US – has steadily ramped up funding for medical and non-medical use cannabis over the past several years. Even more money, public and private, will undoubtedly flow into Canadian cannabis research, as gaps in knowledge close and new scientific and commercial opportunities arise.
Legalization is pushing more and more investment into the cannabis field – a trend that bodes well for future research and the proliferation of potential therapeutics.
Although barriers to research and temporary roadblocks persist, important developments have opened the cannabis industry to new and exciting medical opportunities. Never short of a thrill ride, the future of the industry is bright and ripe with possibilities.
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