Cannabis Clinical Research Dilemma

Legal hassles make it hard to obtain cannabis for studies

As cannabis becomes legal for medical use in many states, researchers seek to know its potential for treating a variety of issues. However, as reported by WCCT, a multisite, full-service early phase contract research organization (CRO) for pharmaceutical, biotechnology and medical device industries, the Drug Enforcement Agency (DEA) classifies it as a Schedule 1 drug, one with “no currently accepted medical use and a high potential for abuse.”

That classification makes it federally illegal to grow, distribute, or use cannabis, thus making it hard to procure cannabis for clinical research. At the moment, the way to get legal cannabis for research purposes is through a contract arranged during the 1970s between the National Institute of Drug Abuse and the University of Mississippi. The five strains of cannabis sold by the university have much less THC and CBD content than industry standards.

Earlier this year, after a vote conducted by FDA’s Peripheral and Central Nervous System Advisory Committee, the United States got one step closer to approving a cannabis-derived medicinal product. Because of that action, there could be a shift in the industry’s ability to do cannabis clinical research.

On April 19, the committee voted 13 to 0 to support the approval of GW Pharmaceuticals’ cannabidiol product, Epidiolex, as well as to support the proposed indication for Epidiolex: the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes. The new drug application (NDA) for Epidiolex attained priority review status from the FDA and has a PDUFA action date of June 27, 2018. GW Pharmaceuticals already makes its cannabidiol product in Canada, where cannabis is federally approved for medicinal purposes.

Now that the committee has supported the approval of Epidiolex, it may lead to an approval from the FDA. While the committee’s decision is not binding, the FDA’s decision on drug approval is consistent with the committee’s vote 87 to 90 percent of the time. If the drug gets approved, a cannabis-derived product would have an “accepted medical use” in the United States, removing cannabis from the DEA’s Schedule 1 criteria and enabling pharmaceutical companies to investigate the medicinal benefits of cannabis and its byproducts through clinical research.

This is the first time that a cannabis-derived product has been considered at an FDA advisory committee meeting, which gives the FDA independent opinions from outside experts on issues related to FDA-regulated products. Normally, the FDA convenes an advisory committee for its pre-market review process when a marketing application contains complex and unusual issues. As of now, the FDA has approved three synthetic cannabinoids that have avoided legal issues.

If the FDA does approve a cannabis-based product, and there is a high demand for further scientific and clinical research in medicinal cannabis, drug companies who want to start clinical development programs will need partners that fit very specific criteria. They include deep understanding of the regulatory concerns about cannabidiol products, expertise in preparing for FDA submissions and interactions, experience in first-in-human studies, ability to conduct pivotal Phase 1 clinical studies and well-documented procedures for storage, handling, and administration of sensitive products.

 

 

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