The US Food and Drug Administration (FDA) has approved America’s first cannabis derived drug.
Big pharma’s drug Epidiolex is designed to treat two rare forms of epilepsy and is made from cannabidol, a component of marijuana that does not give users a high.
According to a statement from GW Pharmaceuticals, the UK-based biopharmaceutical company that makes Epidiolex, “The drug is the “first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs”
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The approved drug is a synthetic compound that mixes both natural and artificial ingredients and is due to be available in Autumn.
RT reports: Administered as a thick oil, CBD was found in clinical trials to drastically reduce seizures in patients suffering from Dravet and Lennox-Gastaut syndromes.
Unlike THC, cannabis’ other active component, CBD does not induce a high. Before Epidiolex can be brought to the market, however, the FDA will have to reclassify CBD, which is currently listed as a Schedule 1 drug alongside cocaine, heroin and LSD.
While Epidiolex will only be available to people suffering from two rare conditions, the approval represents a step forward for medical marijuana research, FDA Commissioner Scott Gottlieb said in a statement. The FDA has previously approved synthetic versions of THC to treat nausea in chemotherapy patients, but has never approved any medication directly extracted from the cannabis plant.
“This is an important medical advance,” Gottlieb said. “And, the FDA is committed to this kind of careful scientific research and drug development.”
Marijuana is currently legal for medicinal use in 30 US states, and legal for recreational use in eight of those states. Some states have more stringent definitions of ‘medicinal marijuana’ however. Louisiana, for example, only allows patients to consume cannabis-based medicine in oil or pill form, while other states limit medicinal marijuana to patients suffering from a select few rare illnesses.
The FDA’s approval of Epidiolex is therefore a significant step towards guaranteeing access to cannabis-based treatment for patients across the country. Under the current system, people looking to treat their own or their children’s illnesses with CBD have had to move to states where the compound is legal. Without regulation, they risk inconsistent quality, inaccurate dosing, and uncertainty of supply.
Dravet syndrome appears early in children and causes frequent seizures, hyperactivity, and impaired motor skills. Lennox-Gastaut syndrome also begins in childhood and causes multiple types of uncontrollable seizures. An estimated one in five patients with either condition die before the age of 20.
Activists claim that CBD can be used to treat a long list of ailments, including AIDS, cancer, Parkinson’s Disease, schizophrenia, arthritis, and strokes. The FDA has taken a dim view of these claims, and has promised to take legal action against companies marketing unregulated CBD products to treat serious illnesses.
“We’re especially concerned when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits,” said Gottlieb.