Current Landscape of Cannabis Clinical Research
As it stands, cannabis is classified as a Schedule 1 drug by the Drug Enforcement Agency (DEA). According to the DEA, a drug is classified as Schedule 1 if it has “no currently accepted medical use and a high potential for abuse.”1
Due to this classification, it is federally illegal to grow, distribute, or use cannabis, making it difficult to obtain cannabis for clinical research. Currently, the only source of legal cannabis for research purposes is through a contract established during the 1970s between the National Institute of Drug Abuse and the University of Mississippi.2 Unfortunately, the university only sells five strains, all of which contain far less THC and CBD content than industry standards, with three strains having no detectable CBD content (CBD is the component of cannabis that is most often associated with medicinal uses).3
However, after a recent vote conducted by FDA’s Peripheral and Central Nervous System Advisory Committee, the United States has moved one step closer to the approval of a cannabis-derived medicinal product. This may also signal a shift in the industry’s ability to perform cannabis clinical research. On April 19, 2018, the committee voted unanimously (13 to 0) to support the approval of GW Pharmaceuticals’ cannabidiol product, Epidiolex.4 More important, however, is that the committee voted in support of the proposed indication for Epidiolex: the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes. The new drug application (NDA) for Epidiolex received priority review status from the FDA and has a PDUFA action date of June 27, 2018. Currently, GW Pharmaceuticals manufactures their cannabidiol product in Canada, where cannabis is already federally approved for medicinal purposes and the burdens US manufacturers face don’t exist.
Cannabis Clinical Research: Looking Forward
The advisory committee’s decision to support the approval of Epidiolex is significant, because it could very well signal an approval from the FDA. Although the advisory committee’s decision is not binding, the FDA’s decision on approval aligns with the advisory committee’s vote 87-90% of the time.5,6 If approved, a cannabis-derived product would then have an “accepted medical use” in the United States, excluding cannabis from the DEA’s Schedule 1 criteria. This would allow pharmaceutical companies to investigate the medicinal benefits of cannabis and its byproducts through clinical research.
Epidiolex is the first cannabis-derived product to be considered at an FDA advisory committee meeting. Advisory committees provide the FDA with independent advice from outside experts on issues related to FDA-regulated product. The FDA will typically convene an advisory committee during their pre-market review process when a marketing application contains complex and unusual issues (for example, the first ever submission of an NDA for a cannabinoid). To date, the FDA has approved 3 synthetic cannabinoids, which, due to their formulation, have avoided legal issues.7
Need for Service Providers
Should there be an approval, and the floodgates opened for further scientific and clinical research in medicinal cannabis, pharmaceutical companies looking to initiate clinical development programs will need partners that fit very specific criteria:
- A deep understanding of the regulatory concerns specifically surrounding cannabidiol products, and expertise in preparing for FDA submissions and interactions.
- Extensive experience in first-in-human studies due to the exploratory nature of these products
- Proven capabilities to conduct pivotal Phase 1 clinical studies that are well-controlled and supported by qualified investigators and clinical staff, for submission to the FDA
- At selected research units: well-documented procedures for storage, handling, and administration of sensitive products, with protections against abuse of any form
WCCT Global looks forward to conducting work in this exciting new space and is prepared to demonstrate its capabilities and expertise to any company looking to develop a cannabis-based product. For more information about how WCCT Global can support your cannabis clinical research program, submit an inquiry here.