Epidiolex Makes History by Becoming the First Cannabis Medicine to Win Federal Approval
October 2, 2018
Written by: Simmone Park In less than two months, history will be made as the first prescription drug made from the cannabis plant hits the market in the United States. Although approved by the Food and Drug Administration (FDA) back on June 25th 2018, it was on September 27th 2018 that the Drug Enforcement Administration (DEA) officially moved the cannabis based drug Epidiolex into a “Schedule V” classification. Manufactured by GW Pharmaceuticals, a British based company with operations in both the U.K. and the U.S., Epidiolex is the first drug derived from cannabis to be put into a category of substances with the lowest perceived potential for abuse. Cannabis itself is currently classified as a Schedule I drug under the Controlled Substances Act, in a category reserved for substances the DEA considers to have the highest perceived potential for abuse alongside drugs like cocaine, heroin, and LSD. Epidiolex is made predominantly from a purified form of the cannabis compound cannabidiol, or CBD, contains less than 0.1 percent tetrahydrocannabinol, or THC, and is a drug created to help treat two rare and severe forms of childhood epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. Dravet syndrome appears during the first year of life and causes frequent fever-related seizures. Typically, children with Dravet syndrome experience poor language and motor skills development, difficulty relating to others, and hyperactivity. Lennox-Gastaut syndrome begins in childhood and is characterized by frequent seizures of multiple types. The vast majority of children with Lennox-Gastaut syndrome experience learning difficulties and intellectual disability. Epidiolex is made for patients aged two years and older. While THC is the best known psychoactive component of cannabis and responsible for the “high” or euphoric feeling, CBD is famous for being the non-psychoactive compound with numerous medicinal benefits. Patients of CBD can find relief from inflammation, chronic pain, anxiety, stress, seizures, and potentially help with conditions such as Alzheimer’s, Parkinson’s, diabetes, arthritis, glaucoma, MS, schizophrenia, PTSD, depression, and epilepsy. One of the factors leading to the approval of Epidiolex at a federal level was that it was such a well-studied and well-controlled product. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.” said FDA Commissioner Scott Gottlieb, M.D. Epidiolex’s effectiveness was carefully studied in three randomized, double-blind, placebo-controlled clinical trials with over 500 patients with Lennox-Gastaut syndrome or Dravet syndrome. When taken along with other medications, Epidiolex was shown to effectively reduce the frequency of seizures when compared with placebo. GW Pharmaceuticals makes Epidiolex using cannabis grown in specialized facilities in the U.K. to maintain quality and consistency and offer a standardized and regulated form of CBD. Although it may seem as though CBD is becoming more and more widely available, especially in states where cannabis is legal (or in states with laws legalizing CBD on its own), it is hoped that the approval of a CBD based drug at the federal level will help reduce the number of unregulated products on the market. One should be careful that they are getting products only from a trusted source, as unregulated cannabis products have been proven to often contain amounts of CBD and THC that are different from what is actually listed on the label. Shortly after the news was announced, GW Pharmacueticals experienced an 8% rise in it’s U.S. listed shares, prompting speculation into deeper research for other cannabis-derived drugs. The DEA’s rescheduling of Epidiolex to Schedule V, while CBD is not scheduled itself but as a substance derived from cannabis and thus remains under a Schedule I classification, have left some wondering whether there could be a future rescheduling of CBD altogether. A spokesperson for the DEA’s public affairs office, Barabara Carreno, purported that the agency had 90 days to put CBD into a lower classification. “We don’t have a choice on that. It absolutely has to become Schedule II or III”. One thing remains for sure: it will be exciting to watch the first Cannabis medicine go to market and see how the situation unfolds over the next few months.