The US Food and Drug Administration announced approval last week of Epidiolex – a new drug derived from cannabis that is designed to treat rare cases of pediatric epilepsy.
GW Pharmaceuticals, a UK-based company manufacturers Epidiolex, which has no THC, but instead relies on the other major cannabinoid present in cannabis products, CBD. THC is responsible for the psychoactive effects of marijuana while CBD itself has not shown to possess them.
As with any drug, approval of Epidiolex has taken time and been contingent on rigorous study of the drug’s effects, But it was helped along this spring by a preliminary approval from the FDA.
Paving the Way
A statement Monday from FDA commissioner Scott Gottlieb implies that a new wave of study may be coming regarding medical uses for the active ingredients in cannabis. He referred to “sound development programs that properly evaluate [the ingredients of cannabis]” as having the potential to “lead to important medical therapies.”
The two main types of epilepsy that Epidiolex targets are Dravet syndrome and Lennox-Gastaut syndrome. Both types are rare, and traditional epilepsy medications have been ineffective in controlling the worst symptoms. The three studies considered by the FDA prior to approval suggest that the CBD in Epidiolex does significantly reduce the risk of seizures and other dangerous symptoms.
The impact of the drug’s approval on the consumer is yet to be seen, as some patients living in states with no legal options for either medical or recreational cannabis will now have a legal way of obtaining medication that could potentially save their lives.
On the other hand, patients in states with legal access to medical and recreational cannabis products may have already been supplementing their epilepsy medicine with CBD oils. The FDA and GW Pharmaceuticals, however, encourage these patients to seek a prescription from their doctor for Epidiolex instead. They argue that the CBD products currently available from dispensaries are not subject to the same level of scrutinous research and therefore cannot be guaranteed to have the same pharmaceutical-grade CBD.
The Off-Label Effect
One significant aspect of Epidiolex’s approval is that while it was designed to treat two specific types of epilepsy, doctors will now be able to prescribe the drug “off-label” in certain cases. What this means is that it may be prescribed as a way to treat other conditions in which traditional treatments have failed, and in which the doctor believes the drug’s properties will be effective for the condition.
This potentially increases the reach of the drug to include other populations, which could lead to other discoveries and further FDA sanctioned uses for CBD and other cannabinioid-derived drugs.
The Cascade Effect
Another ramification of the FDA’s decision to approve Epidiolex is that the DEA (Drug Enforcement Agency) must now reschedule CBD – which it already considers a separate product from marijuana itself – to either Schedule 2 o Schedule 3 status.
When that becomes reality, researchers and CBD manufacturers will have significantly less risk in studying the effects of CBD, with the legal restrictions of Schedule 1 status being lifted. This more than likely means that a wave of new research will be on its way.
Similarly, progress is being made in research on THC and other cannabinoids for other medical uses ranging from pain and severe nausea relief to treating anxiety. The FDA had already approved the study of drugs made from lab-manufactured THC, but Epidiolex is the first cannabis plant-based drug to be approved.
Researchers and activists alike are hopeful that Epidiolex’s approval will cause a cascading effect in which new research doors are opened for exciting new cannabis-related health products.