The drug, which contains CBD, will hit shelves later this year.
In a first, the U.S. government has given a marijuana-derived drug the green light.
Epidiolex, a medication developed to treat two forms of childhood epilepsy, contains a chemical compound found in the cannabis plant, called cannabidiol (commonly referred to as CBD).
It’s the first time the FDA has approved a drug that contains a substance derived from marijuana.
What you need to know:
- The Food and Drug Administration (FDA) approved Epidiolex to be sold in the U.S.
- The drug helps treat seizures generally associated with two of the rarer and most severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome.
- It’s the first time the FDA has approved a drug that contains a substance derived from marijuana.
- The drug is produced by U.K.-based GW Pharmaceuticals.
- Information regarding availability and pricing will be announced by the end of summer, according to the manufacturer.
CBD, the primary chemical component in Epidiolex, comes from the cannabis plant.
CBD has been found to have therapeutic and medical applications and does not have any associated psychoactive effects, unlike its chemical cousin, tetrahydrocannabinol (THC). THC is the psychoactive compound in the plant, which produces the trademark “high”.
In addition to seizures, CBD is used to treat conditions like multiple sclerosis, Parkinson’s disease, and rheumatoid arthritis.
A message from the FDA commissioner:
“This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies,” FDA Commissioner Scott Gottlieb said in a statement.
“The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels,” he added.
What’s next for marijuana and medicine?
The FDA giving Epidiolex the go-ahead for U.S. sales could, however, open the door for other cannabis-derived drugs to also earn government approval. The approval marks a historic first for the U.S. government.
Also, the news comes on the heels of the Canadian government’s passage of legislation to legalize marijuana for recreational use nationwide. Several U.S. states have also legalized cannabis, though it’s still federally prohibited.
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