Challenges to Clinical Trials Remain Following First FDA Cannabis-Based Drug Approval

Sabrina Ramkellawan

Sabrina Ramkellawan, vice president of clinical affairs at TerrAscend and acting president of the Clinical Research Association of Canada

Although a big step has been taken now that the U.S. Food and Drug Administration (FDA) has approved a cannabis-based drug for the first time, one researcher with experience in cannabis studies says how cannabidiol (CBD), the main ingredient behind the effects of such drugs, is classified in the U.S. and Canada will continue to complicate the conduct of clinical trials for potential new treatments.

The FDA on June 25 approved Epidiolex as a twice-daily oral solution for use in treating two types of epileptic syndromes: Dravet syndrome and Lennox-Gastaut syndrome. FDA Commissioner Dr. Scott Gottlieb was on record as praising the “adequate and well-controlled clinical studies” that supported the drug’s approval.

“I hope studies like these push other changes, including recognizing that CBD does not have psychoactive effects, and hopefully helps to reschedule CBD from a Class 1 drug in the U.S. and from a Class 2 drug in Canada—both of which are considered to have high abuse potential—to classifications of lower concern,” says Sabrina Ramkellawan, vice president of clinical affairs at TerrAscend and acting president of the Clinical Research Association of Canada. As an independent consultant, she has had oversight of several observational studies and clinical trials involving cannabinoids.

Ramkellawan notes that current rules, regulations, and laws make it not only difficult to conduct research on cannabis, but even difficult to have cannabis-related businesses in the United States. In a webinar she presented for ACRP, she detailed the current steps to conduct cannabis research, including the limitation of only one approved growing facility (University of Mississippi)—in which the quality of cannabis has come under question.

“I think a [product] like this one approved by FDA clearly demonstrates efficacy, safety, and the medicinal value of CBD,” Ramkellawan says. “Although it might be a long shot for the new proposed Marijuana Freedom and Opportunity Act to be passed, [studies like these] can help.” The Act was introduced in the Senate on June 27, and would completely remove cannabis from the controlled substance list if approved.

“In Canada, the Bill C-45 was passed, which would make Canada the first industrialized country in the world to legalize cannabis by October 17,” Ramkellawan adds. “These Acts not only make cannabis more accessible for people, but with more access comes the need for more research and funding availability—as cannabis will generate revenue to fund more research. It’s a big step, and an exciting time to be in this industry. I foresee that this drug approval is just the start of more to come.”

According to a statement from GW Pharmaceuticals, the U.K.-based biopharmaceutical company that makes Epidiolex, the new drug is the first pharmaceutical formulation of highly purified, plant-based CBD, “a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.”

Authors: Gary Cramer and Sabrina Ramkellawan