The DEA has classified Epidiolex as a Schedule V substance, a substance which has a low potential for abuse and proven medical use, allowing GW Pharmaceuticals to sell it. Epidiolex is a CBD-based medication that is intended to treat rare, difficult-to-treat forms of childhood epilepsy. Studies have shown it to be significantly effective. This classification by the DEA opens the door for other cannabis-based medicines to enter the market.
The Drug Enforcement Administration (DEA) has rescheduled Epidiolex, a CBD-based medication for the treatment of epilepsy, to a Schedule V substance. Schedule V is the lowest classification, including substances with proven medical use and low potential for abuse.
The DEA’s classification allows GW Pharmaceuticals, the UK-based pharmaceutical company that created Epidiolex, to sell the medication in the US market and for patients to access it with a doctor’s prescription.
Epidiolex became the first FDA-approved CBD-based medication earlier this year in June.
“This is yet another validation,” said CEO of GW Pharmaceuticals, Justin Gover, “that if you apply the rigors of science and law to cannabis research, that the regulatory authorities, namely the FDA and DEA, will act and respond to the needs of patients to make these kinds of medications available.”
The FDA and DEA did clarify, however, that its approval of Epidiolex was not a broad approval or rescheduling of CBD itself.
Epidiolex is intended to treat Dravet Syndrome and Lennox-Gastaut Syndrome, which are rare, difficult-to-treat forms of childhood epilepsy.
Epilepsy is the most well-documented condition that CBD is known to treat.
A study by Mayo Clinic in Rochester, Minnesota tested the effects of Epidiolex on children for Dravet Syndrome.
The children were split into two groups, with one group taking Epidiolex while the other was given a placebo. Those taking Epidiolex saw a 39% reduction in seizure frequency. The only side effects were sleepiness and loose stools, which was remedied by adjusting dosage.
Other studies have shown CBD can help some patients become completely seizure-free.
The approval and scheduling of Epidiolex is a breakthrough for the CBD industry, paving the way for similar medications to become approved and scheduled.
Additionally, this event will likely trigger more interest and research into the medicinal value of CBD and perhaps other compounds found in marijuana, potentially leading to the creation of more CBD-based medications.
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