Research has shown that CBD has the potential to treat seizure conditions, like Dravet syndrome. Though CBD doesn't induce the high associated with marijuana use-THC does that-it's now classified as Schedule I, a category that covers drugs with no therapeutic value and high probability of abuse.
The drug, administered as an oil, could significantly improve the quality of life for patients with two types of childhood epilepsy: Dravet syndrome, a genetic illness that kills up to 20 percent of sufferers before age 20, and Lennox-Gastaut syndrome, a form that begins between ages 3 and 5 and causes intellectual disability.
Many companies sell cannabis-based treatments, touting them as cancer cures, pain relievers and anxiety medicines. Rescheduling cannabidiol paves the way for other advanced cannabinoid formulations, like the ones now being researched and developed by scientists on staff at my Colorado-based cannabinoid science business, ebbu.
The drug contains nearly non of the psychoactive chemical from marijuana that makes people high and proved through testing to be effective in treatment of certain pediatric seizure patients.
"Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients", FDA Commissioner Scott Gottlieb, said in a statement today.
The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant.
A major milestone Monday for use of marijuana for treatment of health ailments.
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 approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.
GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD. "We're the world-leaders in cannabinoid science, and I think we expect to stay there for quite some time".
GW Pharmacueticals is expected to announce the US launch for Epidiolex as soon as the DEA reclassifies CBD. Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.