This is history in the making. For the first time ever, the Federal Drug Administration approved a drug featuring an active component from cannabis. Epidiolex, which has been in Stage 3 testing since 2015, is now approved as a prescription treatment for two rare and lethal forms of epilepsy: Dravet’s and Lennox-Gastaut Syndrome. Finally, the FDA approves CBD for epiliespy. Now, how did we get here and what will come next?
The road to success – FDA approves CBD drug after years of testing
It’s been a long road to FDA approval for CBD drug Epidiolex. Beginning in 2008, British drug developers sought to bring the CBD drug to market with five years of preclinical cannabinoid research. Starting in 2013, Phase I clinical testing went underway. At the time the drug was still in its candidacy phase, with the name GWP42006. This new drug, if approved, would also be the first designated drug treatment for Dravet Syndrome. Dravet and Lennox-Gastaut Syndromes are of the most devastating forms of epilepsy. They have a mortality rate three times greater than adult refractory epilepsy. Tragically, the lives these forms take are almost always children. They are also, especially when it comes to Dravet syndrome, relatively drug treatment resistant. This resistance to treatment is a huge reason why the CBD, which proved effective in seizure reduction, gained approval.
In 2014, Epidiolex received its Investigational New Drug status from the FDA, thus commencing Phase 2/3 trials. For 4 years, testing with uniform and positive results came from these trials. In 2017 the drug was recommended for approval by an FDA panel. Finally, just this month, the drug is now available for prescription for children age 2 and over suffering from the rare conditions.
What comes next?
While this may be the first CBD drug to gain approval from the FDA, it may not be the last. In the press release issued June 25, the FDA states they are willing to review other cannabis drugs, provided they can boast they same kind of uniform dosing and effectiveness as was proven in the Epidiolex clinical trials. However, they are clear, that any kind of illegal marketing of CBD products, claiming cures for diseases without proper dosing and testing to support the claims will be hearing from them. Marijuana is still a Schedule 1 substance so cannabis CBD falls into this designation. However, with the legalization of hemp and its derivatives in 2014, industrial hemp CBD falls into a gray area outside these bounds. However, the FDA credits their power of persuasion over the DEA with drug scheduling recommendations.
Rescheduling of cannabis by the DEA as a result of the approval of a CBD drug from the FDA still hangs in balance. However, in the meantime, thousands of children and their families have new hope. For these families, this new CBD drug just may be the reason their son or daughter lives to see adulthood. Semantics aside, everyone has cause for celebration.