By Nick Lindsey, HighTimes.com
The first FDA-approved, cannabinoid-based pharmaceutical drug is now for sale in the U.S.
After clearing all regulatory requirements, GW Pharmaceuticals’ CBD-based drug Epidiolex is now available in all 50 states. Although the U.S. government is now allowing this drug to be sold, the federal government still classifies actual cannabis as a Schedule I illegal substance.
Epidiolex Available by Prescription
Epidiolex is a seizure medication derived from cannabinoids that are naturally occurring in the cannabis plant. In particular, the drug is designed for patients 2-years-old and up. It is meant to treat two specific types of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome.
Now that Epidiolex has received all necessary approvals, it is essentially treated as any other pharmaceutical drug. That means that patients with a prescription will be able to buy it. And GW Pharmaceuticals expects the drug to be covered by most insurance plans.
Notably, the drug will now be available to all patients regardless if they live in a medical marijuana state.
This is not the first time Epidiolex has made headlines. In fact, the drug’s move through the regulatory process has attracted a decent amount of attention.
For starters, an advisory committee recommended Epidiolex for approval back in April. That approval came relatively quickly when the FDA approved it in June.
Then, Epidiolex cleared the last remaining roadblocks in September. That month, the U.S. Department of Justice and the DEA both gave the drug the approvals needed to move it into the market.
In particular, the law enforcement agencies classified Epidiolex a Schedule V drug. Under that classification, the product is allowable as a prescription drug.
Interestingly, while Epidiolex was given Schedule V status, actual marijuana–from which Epidiolex is derived—remains a Schedule I drug. That category is reserved for “drugs with no currently accepted medical use and a high potential for abuse.”
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