The United States Food and Drug Administration is catching up with public opinion/consumption. This week the FDA approved the first drug cannabidiol (CBD) derived from cannabis. The advisory committee had been reviewing the drug Epidiolex since April.
In statements by both the FDA and GW Pharmaceuticals on Monday, June 25, 2018, acknowledged the approval of the drug.
GW Pharmaceuticals stated their drug- Epidiolex- 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.”
Epidiolex is a twice-daily oral solution for patients age two years and older to treat epileptic syndromes including:
- Dravet Syndrome – a severe form of epilepsy that occurs in the first year of life, and brings on rare genetic dysfunction of the brain.
- Lennox-Gastaut Syndrome – is a form of pediatric epileptic syndrome characterized by multiple seizures usually between the ages of three to five years old.
CBD- the active cannabis component in Epidiolex- is one of 80 active cannabinoids chemicals that does not produce a psychoactive high. The drug is void of tetrahydrocannabinol (THC) that does provide a high.
FDA Commissioner Dr. Scott Gottlieb said in a statement, “This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients.”
Despite this approval, the US government continues to classify cannabis as a controlled substance with no medical use similarly to heroin and LSD. Twenty states allow medicinal use of marijuana, and nine state and the District of Columbia have legalized recreational use.
There is still a lack of scientific information about marijuana and CBD- its benefits and risks- that continue to hold up federal legalization.
Therefore there is one more big hurtle before sales of Epidiolex can begin. The Drug Enforcement Administration must formally reclassify CBD with federal medical approval. That decision is expected within 90 days…
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