The U.S. Food and Drug Administration on Monday approved Epidiolex, which contains marijuana compound cannabidiol or CBD, to treat two types of severe epilepsy. Where is weed legal? 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.
Marijuana now has an accepted medical use. Cannabis-derived CBD products are available where recreational marijuana is sold, though CBD derived from industrial hemp faces fewer regulations and is even stocked by some grocery stores.
"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement", said Philip Gattone, president and CEO of the Epilepsy Foundation.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", FDA Commissioner Scott Gottlieb said.
Epidiolex is based on cannabidiol, more commonly called CBD, rather than THC, which is the component associated with psychoactive effects. The move could open the doors to other marijuana-derived medications as well as ease heavy restrictions on marijuana-related research.
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"I preferred this to some of those other options because it's is a commercial product that has gone through rigorous testing", said Hendershot, who lives in Rochester, New York. This is the approval of one specific CBD medication for a specific use.
A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program. 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.
Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.
The FDA is not required to follow the advisory panel's advice but usually does.
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. "I really don't think [the FDA approval is] going to affect us much". Another 20 states allow medical marijuana, but the USA government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.
Federal agencies have 90 days to determine the scheduling of Epidiolex.