FDA Approves First Marijuana-Derived Prescription Medication

Sarah Randolph, PharmD, RPh
Clinical Account Executive

On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved Epidiolex (cannabidiol). Epidiolex is an oral solution which contains a purified drug substance that is derived from a component of the marijuana plant. The cannabidiol in this drug is a (CBD) component of marijuana but does not cause euphoria or intoxication as compared to the tetrahydrocannabinol (THC) component.

At this time, Epidiolex has been approved only for the treatment of seizures related to Lennox-Gastaut and Dravet syndromes. This is the first FDA-approved medication for Dravet syndrome, which effects young children under the age of five. This condition results in frequent seizures, delayed motor skills and intellectual disability.

The substance CBD is currently classified as a schedule 1 (C-I) by the U.S. Drug Enforcement Administration (DEA) because it is a component of the marijuana plant. Schedule 1 drugs are considered to have a high potential for abuse and not accepted as medical treatment within the U.S. There are currently no prescription or over the counter medications in the schedule 1 classification. Within the clinical trials to support safety and efficacy of Epidiolex and subsequent FDA-approval, the developer GW Research LTD also conducted studies to assess the abuse-potential of the drug. The clinical studies gained a DEA classification that would allow medical use. The DEA will review this data in collaboration with the FDA and then make a scheduling determination for this product, separate from the existing C-1 schedule for marijuana.

A release date has yet to be provided as a DEA scheduling determination must be made before its market debut. Given its pediatric indication, it is unlikely that this specific product will process through Workers’ Compensation claims. However, this is the first marijuana-derived (naturally sourced versus synthetic) product to be approved through careful scientific research and development. FDA Commissioner Scott Gottlieb, MD stated, “This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use.”

 

References:
1) The US. Food and Drug Administration. “FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rate, Severe Forms of Epilepsy.” June 25, 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm
2) The US. Food and Drug Administration. “Statement by FDA Commissioner Scott Gottlieb, MD.” June 25, 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611047.htm