The drug's approval permits its use in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.
The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year. Under the Controlled Substances Act, marijuana is a Schedule I drug, meaning it has a high potential for abuse and no recognized medical objective (heroin, LSD, and ecstasy are also Schedule I drugs).
As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it.
"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", Gottlieb said.
For medical marijuana advocates, it's a clear vindication of a fundamental premise of a decadeslong movement: that cannabis can have legitimate medical applications and it isn't the bogeyman that the federal government has long made it out to be.
Commenting on the agency's decision, NORML Deputy Director Paul Armentano said: "The FDA's approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis".
Cannabidiol is one of more than 80 active cannabinoid chemicals, yet unlike tetrahydrocannabinol, or THC, it does not produce a high. It's just a gray area, and many are erring on the side of caution and not doing business in those states.
North Korea scraps 'anti-US imperialism' rally as ties appear to warm
He said that framework couldn't be filled out without, Kim "making clear his intent to denuclearize", Pompeo said. Secretary of State Mike Pompeo is also expected to visit Pyongyang soon to lead the nuclear negotiation process.
In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for. As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire.
FDA's Gottlieb warned about the use of CBD products with "unproven medical claims".
The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption.
The FDA is not required to follow the advisory panel's advice but usually does.
Some have said that they have no intention of switching to the new prescription CBD drug because the products they're using are helping their children. The decision caps decades of work by the company to gain approval in the USA for a medicine derived from the cannabis plant.
Justin Gover, chief executive officer of GW Pharmaceuticals, described the approval in the statement as "a historic milestone". This treatment we have studied for the last five years. The FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials. That decision is expected within 90 days.