"Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality and most importantly, that these products have been proven safe and effective for patients", Gottlieb added.
The U.S. Food and Drug Administration has approved a marijuana-deriveddrug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood.
While most hemp-derived CBD companies are rapidly growing their businesses without repercussion or worry, many cannabis CBD businesses are hesitant about selling products in states where marijuana is not yet legal.
British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis.
The goal is have it available in pharmacies by the end of the year, said Orrin Devinsky, a pediatric neurologist and director of the New York University-Langone and Saint Barnabas Comprehensive Epilepsy Center in Livingston, who co-authored the research. The non-intoxicating compound now falls in line with marijuana, which has "no now accepted medicinal use" in the eyes of Uncle Sam.
This reschedule should make it easier for researchers to study CBD for its potential health benefits.
"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.
It's meant to treat severe seizures in children caused by two rare forms of epilepsy. 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.
FDA's Gottlieb warned about the use of CBD products with "unproven medical claims".
Cannabidiol is structurally unrelated to other anti-seizure medications.
Now with the approval of Epidiolex, a drug that will not produce an euphoric "high" feeling in the user - Devinsky said he expected CBD would be moved down to a schedule 4 or 5 drug, which is one that poses a low potential for abuse and dependence.
There have been several national news stories about parents exploring the treatment and it's worked. More importantly, a DEA representative recently affirmed that outlook, telling Leafly reporter Ben Adlin that if Epidiolex is approved, the DEA will "absolutely" reschedule CBD.
The FDA is not required to follow the advisory panel's advice but usually does. GW Pharmaceuticals grows the plants in the United Kingdom. "I really don't think it's 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.
Epidiolex is under review in Europe as well, and GW expects a decision from the European Medicines Agency in the first quarter of next year.
The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way.