IN BRIEF

The Changing Medical and Legal Landscape for Cannabidiol

October 22, 2018
Written by

With FDA approval of EpidiolexR, the pace of research on CBD medication is likely to increase.

The first federal approval of a non-synthetic, plant-based cannabis drug for two epilepsy syndromes may help change the legal landscape for medical professionals who wish to study similar formulations – and lead to further treatments for pediatric patients.

In June, the U.S. Food and Drug Administration approved cannabidiol (CBD) under the brand name Epidiolex, for the treatment of seizures associated with Lennox-Gastaut and Dravet syndromes. Both are considered severe, treatment-resistant forms of epilepsy, and children with the conditions can have dozens of brief seizures per day.

That approval set in motion the rescheduling of cannabidiol by the FDA. Marijuana (like heroin and LSD) has been considered a Schedule I drug, meaning it has no accepted medical use and has a high potential for abuse. Because of its Schedule I status, the trials that ultimately established cannabidiol’s efficacy and safety were conducted under especially difficult regulatory conditions, says Anup Patel, MD, section chief of Neurology at Nationwide Children’s Hospital.

Dr. Patel was co-lead author of a May 2018 study in the The New England Journal of Medicine, which showed cannabidiol could lead to a significant reduction in the number of drop seizures for patients with Lennox- Gastaut syndrome. He and Nationwide Children’s also participated in a 2017 NEJM study showing cannabidiol could reduce seizures for patients with Dravet.

“First, the FDA approval of cannabidiol will change the lives of many families who deal with Lennox-Gastaut and Dravet, and that’s very important,” Dr. Patel says. “Second, the rescheduling by the DEA will ultimately make cannabidiol easier to study in the future.”

Dr. Patel began studying cannabidiol at Nationwide Children’s in 2014 and had to obtain a special license from the Drug Enforcement Agency under the Controlled Substances Act to dispense the drug. The FDA approval means that any physician could potentially write a prescription for the medication; the DEA rescheduling means that a special license and DEA oversight will no longer be needed for trials.

Dr. Patel and other academic medical researchers continue to emphasize that the medication approved by the FDA is greater than 98 percent CBD, and it has no psychoactive properties. Care providers and consumers should not confuse it with other products labeled “cannabidiol” that make a variety of health claims and can be obtained over the internet and from other outlets.

“What we wanted to do, and have done, is put this specific medication through the same rigorous research process as any other medication on the market,” says Dr. Patel. “That’s why the FDA approved it, that’s why the DEA is rescheduling it, and that’s why we now have the potential for other research and treatments.”

 

References:

  1. Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of cannabidiol for drug-resistant seizures in Dravet syndrome. The New England Journal of Medicine. 2017 May 25; 376(21):2011-2020.
  2. Devinsky O, Patel AD, Cross JH, Villanueva V, Wirrell EC, Privitera M, Greenwood SM, Roberts C, Checketts D, VanLandingham KE, Zuberi SM; GWPCARE3 Study Group. Effect of cannabidiol on drop seizures in the Lennox-Gastaut syndrome. The New England Journal of Medicine. 2018 May 17; 378(20):1888-1897.

Photo credit: Nationwide Children’s