Cannabis-derived epilepsy medication eliminated from controlled substances list by DEA
A cannabis-derived pharmaceutical drug called Epidiolex has officially been banished from the U.S. Drug Enforcement Administration’s (DEA) list of controlled substances.
The medicine, which is FDA-approved, is the creation of GW Pharmaceuticals. Headquartered in the United Kingdom, the British company is also responsible for producing multiple sclerosis medicine Sativex — an oromucosal spray containing the psychoactive compound THC (tetrahydrocannabinol).
Changes to Epidiolex’s classification were effective immediately following the DEA’s announcement on April 6, 2020. Initially, the company anticipated that its pharmaceutical product would be decheduled in September 2018, but instead it was shifted to Schedule 5; alongside products containing small amounts of Lyrica, Motofen and codeine.
By the end of the day on which the DEA descheduling of Epidiolex took place, shares of GW Pharma (NASDAQ:GWPH) were up 5.84 percent.
Epidiolex is the only FDA-approved prescription containing CBD
Developed for use among children aged two and above, Epidiolex bagged approval from the Food and Drug Adminstration (FDA) in June 2018. The cannabinoid-based medicine is specifically created to relieve seizures in parents with two rare types of epilepsy — Dravet syndrome and Lennox-gastaut syndrome.
Epidiolex contains a highly purified cannabinoid known as ‘CBD’ — the abbreviation for ‘cannabidiol’. Although it is derived from the cannabis plant, it does not induce a “high” in consumers. Epidiolex has demonstrated incredible potential in easing the muscle spasms and jerks that patients experience when they have an epileptic fit.
During the initial launch year of being made available to prescribed patients – 2019 – Epidiolex pulled in $296 million in revenue. Pharma CEO Justin Gover described the launch year as “incredible” during an interview with CNBC.
“It’s an incredible launch year for any medication [that] I think proves that this kind of medicine is really making a difference to patients,” expressed Gover. “It shows real value to the health-care system, and it sets us up, I think, in a very nice way for what should be another great year for us in 2020.” Considering the DEA’s descheduling of Epidiolex, he was right.
Process of prescribing Epidiolex for epilepsy will be simplified
Following the DEA’s descheduling of Epidiolex, it will be easier for physicians to prescribe the medicine to patients. Previously, when Epidiolex was a Schedule 5 drug, physicians were required to inform the Agency each time it prescribed the CBD-based pharmaceutical for epilepsy.
The DEA’s descheduling of Epidiolex marks the first time that the Agency has ever removed any form of cannabis from Schedule I on the list of controlled substances. According to GW Pharma, the company will start “implementing these changes at the state level.” The changes will take effect across its network of distributors throughout the United States, where 33 states have legalized medical cannabis and 50 have legalized hemp-derived CBD.