Historic milestone as first marijuana-derived medicine approved by FDA

In a landmark announcement the US Food and Drug Administration (FDA) has approved a new drug consisting of cannabidiol (CBD), to treat two rare forms of severe childhood-onset epilepsies. CBD is a cannabinoid derived from marijuana and the FDA's approval of this new medicine will force the US Drug Enforcement Administration (DEA) to reschedule the compound from its current restricted level.

CBD is one of over 100 different cannabinoids found in marijuana. Unlike its more psychoactive cousin, tetrahydrocannabinol (THC), CBD generally doesn't cause the commonly associated euphoric effects marijuana is known for. A rapidly growing body of evidence is finding a whole host of different beneficial medical uses for CBD, from controlling chronic pain to improved anxiety disorders. But the strongest research in CBD's favor has been its ability to reduce the frequency of uncontrollable seizures in epilepsy.

The newly approved CBD medicine, called Epidiolex, has been formulated to treat two severe forms of childhood-onset epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome. Both conditions are notoriously treatment-resistant and this final FDA approval comes after years of research and clinical trials working to establish the efficacy of this treatment.

"This approval is the culmination of GW's many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine," says Justin Gover, CEO or GW Pharmaceuticals, a company at the forefront of this drug development process.

"These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care."

One of the fascinating implications of this FDA approval is that it will force the DEA to redetermine its current restrictive scheduling of CBD. For decades marijuana, and all its chemical components, has been classified as a Schedule 1 drug. This is the most restrictive level of drug control the US federal government has. It means a drug has a high potential for abuse, no safe use and no accepted medical use. Other Schedule 1 drugs include heroin and LSD. Cocaine and methamphetamine are Schedule 2 drugs.

In 2016 the DEA went even further in restricting broader uses of marijuana-derived compounds, clarifying the Schedule 1 listing to include all "marijuana extracts" including any derived cannabinoid. While many US states have moved to legalize both medical and recreational cannabis products, federal law still stands in direct contrast, maintaining the Schedule 1 classification.

For Epidiolex to become a legally available drug that doctors can prescribe the DEA will have to reschedule CBD. It is estimated that this rescheduling determination will occur within 90 days from this new FDA announcement. It's unclear how the DEA will approach this rescheduling decision but it seems unlikely to shift marijuana, as a whole plant, down from its Schedule 1 classification. What is possibly more likely is that CBD will be specifically separated from marijuana as its own unique compound, and classified at a more accessible level.

Either way this is a milestone moment in the broader medical and legal acceptance of drugs derived from substances previously considered taboo and medically useless. The FDA's approval of CBD as a legal medicine will indirectly allow many off-label prescriptions for the compound but it could also have much larger repercussions.

One legal writer has gone so far as to hypothesize the approval of Epidiolex as starting a domino effect of marijuana acceptance, ultimately leading to the legalization of the plant in the United States. That may be an extreme outcome, but in the short-term this FDA approval is an encouraging moment of legitimization for a field of medical research that has long been pushed the fringes.

Source: FDA