By some measures, consumer interest appears to be moving away from traditional high-potency THC-based products and toward CBD. Patel said the drug trials generated good information about safety and side effects of CBD use, and the FDA approval opens doors for more research on the benefits and effectiveness of CBD on other conditions.
GW Pharmaceuticals manufactures another cannabis-derived drug, Sativex, which helps treat muscle spasms from multiple sclerosis. Epidiolex contains CBD, a cannabis chemical compound skyrocketing in popularity and driving what is estimated to have doubled into a $200 million market in 2018.
"This is an important medical advance", Gottlieb said.
Several states have legalized CBD oil specifically for the treatment of intractable epilepsy or seizure disorders. According to the New York Times, analysts expect Epidiolex to cost $2,500 to $5,000 a month.
CBD oil is now sold online and in specialty shops across the US, though its legal status remains murky. It's in phase 3 testing for a potential approval in the U.S. The company is also working on cannabinoid programs against glioblastoma, schizophrenia and more.
The immediate impact of Monday's approval on these products is unclear.
"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters.
"Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", he said.
The FDA is not required to follow the advisory panel's advice but usually does.
Most CBD producers sidestep the issue by making only broad claims about general health and well-being.
The FDA seal is nonetheless seen to be a boon for the broader industry.
A company representative said the list price for the medication had not been set yet. "I really don't think it's going to affect us much".
The drug should provide a more reliable alternative than the homemade cannabis oil parents for years have made for the children, said Devinsky, who once treated Vivian Wilson of Scotch Plains, a toddler with Dravet syndrome. The agency is expected to do so within 90 days.
In clinical trials, children with Dravet syndrome who took Epidiolex experienced 39 percent fewer seizures; those with Lennox-Gastaut syndrome saw a 37 percent decrease.
Critically, the drug will be available to patients nationwide, not just in states where cannabis is legal for medical purposes. Previous year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.
Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).
Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA.
The component in this newly approved drug is CBD (cannabidiol), which is part of the sativa marijuana plant. And the company plans to continue importing the medicine, bypassing onerous USA regulations on manufacturing restricted substances.