Cannabis Lacks Traditional R&D, but That's About to Change
Research institutions and private companies are now able to pursue ambitious cannabis research programs. But there is still a long way to go.
Historically, it has been challenging to get research on the cannabis plant off the ground. Academic research efforts have been hampered by a lack of funding or strict regulations restricting plant access.
But thanks to progress in the legalization of the plant in Canada, some parts of the United States, and a handful of European Union nations, research institutions, and private companies alike are now able to pursue ambitious cannabis research programs. While these trials aim to improve our understanding of this unique plant, there is still a long way to go.
298 THC studies worldwide
There are 298 clinical trials on Tetrahydrocannabinol (THC) underway worldwide. One hundred and fifty-four are taking place in the U.S., 78 in Europe, and 32 in Canada. The U.S. Drug Enforcement Administration (DEA) also recently announced its initial acceptance of numerous cannabis grower applications to expand the production of federally-approved research-grade cannabis. Incredibly, the production of cannabis for research was previously limited to just one facility to serve the entire nation.
With all of this activity, plus several recent high-profile entries into the market sector (like the acquisition of GW Pharmaceuticals by Jazz Pharmaceuticals for $7 billion), the pharmaceutical industry is watching cannabis research closely and responding.
Wider mainstream acceptance of cannabis
Cannabis legalization efforts have mainly focussed on the legalization of cannabis for medicinal use. Academic research on cannabis proves the drug to be capable of eliciting beneficial therapeutic effects. There is a growing consensus of medical professionals supporting the use of medical cannabis for treating a variety of health conditions, including severe ailments like Alzheimer's disease and epilepsy, to more common daily applications for improving pain, sleeping problems, and anxiety.
Because doctors practice evidence-based medicine, R&D will be crucial in bringing to light the necessary evidence for healthcare governing bodies to review guidance on cannabis for medicinal use and recommend it in practice. These healthcare governing bodies often cite a lack of validated clinical data as a critical hurdle for approving cannabis-based medicines. The progress of additional clinical trials from R&D firms can do a significant amount to change perceptions and provide accurate information on safe dosing regimens and potential efficacy.
Because of cannabis' status as a non-lethal herbal-based medication, which makes its effects felt through activating receptors in the body's natural endocannabinoid system, cannabis–based medicines are gaining approval across Europe and the U.S. Food and Drug Administration (FDA). Drug approvals for cannabis-based medicines, including Sativex, Epidiolex, and Nabilone, are paving the way for greater innovation and research investment in studies and trials for cannabis-based treatment.
Beyond the medical field, cannabis-focused R&D projects can also be a valuable source of data for lawmakers who have the power to address cannabis policy within their jurisdictions. Greater numbers of clinical trials and ongoing R&D projects provide a wealth of expertise for lawmakers to draw on when constructing new medical cannabis frameworks. Overcoming decades of negative stigma for herbal medicines takes time to reach broader acceptance. Although this trend is arguably more prevalent in Europe than in the U.S., it is now sweeping the globe.
R&D means a better experience for cannabis patients
One of the most notable innovations taking place within cannabis R&D at the moment is the investigation of alternative drug delivery systems for medical cannabis patients.
Recreational users commonly consume through inhaling smoke or vapor. But for many medicinal patients, it is unrealistic to expect them to smoke their medicine. For health reasons, they may lack the space to smoke regularly, or it could simply be a personal preference. Additionally, doctors will be highly reluctant to embrace prescribing anything that can be harmful to the lungs or prescribe a practice that fundamentally suffers from imprecise dosing.
Creating alternative drug delivery systems for cannabinoids—such as slow-release gel caps, inhalers, edibles, nasal sprays, and topicals—allows these patients to access cannabis medicine without the need for smoking. These formats are also more similar to what doctors will be familiar with working with, and so will help to make health providers more comfortable with prescribing cannabis medicines.
Rather than asking patients to use a specific weight of cannabis flower, which can vary genetically from batch to batch and be unpredictable in its effects, doctors can prescribe pills, nasal sprays, topical patches, etc, providing easier instructions and ensuring that each dose administered will be identical. With this reliability, it becomes easier for doctors to see the impact of different dosing regimens and create the best-specialized regimen for each patient.
Cannabis as a traditional pharmaceutical drug
Natural cannabis flower contains several hundred active ingredients in the forms of cannabinoids, terpenes, and flavonoids. As a result, it is challenging to replicate the full-spectrum and infinite combinations of ingredients that natural cannabis can produce in a synthetic laboratory environment. Successfully translating these combinations into a traditional pharmaceutical R&D environment has the potential to enable advancements in cannabis research for patients.
Today's pioneers in the sector tend to concentrate only on formulations of cannabidiol (CBD), THC, or a combination of the two. While this may appear rudimentary when you consider the many varieties of other cannabinoids and terpenes created synthetically, it is essential to keep in mind pharmaceutical approvals for various combinations of ingredients are lengthy and costly. Using more than one active ingredient in a formulation adds extreme complexity to the approval process, already complicated for pharmaceutical cannabinoids.
The process of medicine development and approval in the United States generally favors synthetic medicines. So there has been a push to produce synthetic cannabinoid isolates that are more than 99 percent pure.
These synthetic cannabinoids are either produced through biocatalysis or other chemical reactions. The consistency in quality of these synthetic cannabinoids could significantly impact the wider industry, despite a general preference in some European countries for full-spectrum herbal-based medicines. If perfected, many researchers believe that synthetic extracts will offer lower-cost production methods than those currently employed to cultivate, harvest, and process natural cannabis biomass.
Currently, the conversion of CBD to minor cannabinoids cannabinol (CBN) and delta-9 THC is proving to be a more efficient way of deriving these molecules than distillation from natural cannabis extract. The real advantage of this kind of synthesis is likely to produce these and other minor cannabinoids typically present in only trace amounts in raw cannabis. These minor cannabinoids often have distinct chemical properties of their own, which could be helpful therapeutically if they can be produced with good purity standards in bulk to be studied and applied strategically. Through synthetic chemistry and cannabis R&D, this once-hypothetical research avenue is now a reality.