The intention of this post is to give a review of the 50 years worth of experience supporting cannabis drug development via FDA clinical trial applications. Links for the FDA’s discussion on this are available at the bottom if you’d like to further research the resurgence in cannabis research applications. Before we begin this article, let us review the few FDA approved cannabis drugs.
- Epidiolex (2018): In June 2018, the U.S. Food and Drug Administration (FDA) approved Epidiolex, a prescription medication containing cannabidiol (CBD), for the treatment of seizures associated with two rare and severe forms of epilepsy—Lennox-Gastaut syndrome and Dravet syndrome. Epidiolex was the first FDA-approved drug derived from marijuana.
- Dronabinol and Nabilone (Various Approvals):** Dronabinol and nabilone, both synthetic cannabinoids, have been approved for medical use to treat conditions such as nausea and vomiting associated with chemotherapy and to stimulate appetite in patients with AIDS.
- Sativex (Not Approved): Sativex, an oral spray containing THC and CBD, has been developed for the treatment of spasticity in multiple sclerosis. As of my last update, it had not received FDA approval in the United States.
It's essential to note that the regulatory landscape regarding cannabis and its derivatives is continually evolving, and additional cannabis-based drug applications may have been submitted or approved since my last update. Changes in legislation, scientific advancements, and shifts in public opinion can influence the trajectory of cannabis-based drug development.
Let’s begin with the major therapeutic areas that cannabis FDA therapies fall into. First should be no surprise to even the novice cannabis consumer or researcher 53% of applications are for Addiction or Pain Management treatments or therapies. Second we have neurology at 19% due to cannabinoids neuroprotective traits. In third place we have immunology and inflammation at 14%. Last but certainly not least we have Psychiatric application at 9%. Each one of these categories is vast in it’s own rights. However, when examining peer reviewed research on cannabis one will begin to notice that the majority of it covers very broad sections of medicine rather than hyper focusing on one particular ailment or disease. This is due to the majority of cannabis clinical trials being observed as what is commonly referred to as adjuvant therapy.
Adjuvant therapies are a drug that is meant to coincide with a already approved FDA drug. Whether that drug be for cancer treatment, anxiolytic (anti-anxiety), pain management, neurodegenerative disease so on and so forth. These therapeutic approved drugs are meant to enhance the relief of a already approved medical treatment. Prior to 2010 the majority of research on cannabis drug development was done via inhalation of the inflorescent (flower) materials. With a rise in oral applications as of the 90’s. Since 2010 a rise in varies ingestion methods has directly correlated to the rise in applications. These methods include but are not limited to, baked goods, tinctures, capsules/pills, extracts, vaporizers etc. We can thank the cannabis industry as a whole for this, both the marijuana and hemp spaces.
Over the 50 years that the FDA has been accepting cannabis drug applications. They’ve received over 800 applications. The majority of these have been in the last 15 years. The correlational increase in cannabis drug development also directly ties to botanical drug development. Most likely this is due to a rising awareness of botanical chemistry and alternative medicine modalities. It is important to note that the majority of “botanical” drugs that are approved by the FDA I.e. marinol & drabinol are synthetic version of a cannabinoid or botanical derivative. In other words, the drug was not naturally derived. To date a naturally derived cannabis drug has not been approved for marketing to cure or prevent any disease. However, we do have epidolex which was the first cannabis derived drug approved for the treatment of two seizure disorders, these disorders are a special circumstance when it comes to drug approval though. Further elaboration on this aspect of cannabis drugs comes down to a lack of understanding from the cannabis industry as a whole regarding drug development.
Most drug applications regarding cannabis with the FDA can’t even pass the pre-clinical animal and toxicology trials due to a myriad of supply chain, purity, and consistency issues. So most groups can not provide support for their drug when it comes to consistently producing the proposed formula time and time again to meet potential market demand. This issue comes down to many various factors of the industries structure and can not be blamed on one particular pain point. However, it pre-dominantly starts with that fact that we are dealing with plant material in the beginning of the drug development cycle.
In conclusion the FDA is receiving more Cannabis & Cannabis-Derived Products (CCDP’S) applications and appears to be in support of a robust birth of research regarding the development of these drugs. However, as a entire industry seeks to be the second approved to market cannabis drug we are failing on more fronts than we accept to admit. Many businesses talk about how they’re here for the medicine but can’t supply a simple chain of custody on where the botanical material was grown, extracted, then formulated to final product. This is issue number 1 of 100 that I personally see in having a FDA approved drug to prevent or cure disease that is derived from cannabis. However, as we grow and as we clean up the industry, I believe we will see a whole plant derived drug be approved by the FDA. It is appearant when examining the data of botanically derived drugs that the FDA supports the application of naturally derived substances. However, most of the companies approved for adjuvant therapies or for marketing of a naturally derived drug don’t have the dollars to get the drug into public hands. If you would like to research these issues more please visit the links below. Educate yourself and help spread the word about natural medicines.