Here’s an update everybody in the medical cannabis community has been waiting for: the U.S. Drug Enforcement Administration has given cannabis-derived drug Epidiolex a Schedule V classification today.
This is the first time a cannabis-based medication has been rescheduled in the United States.
What is Epidiolex, exactly?
Epidiolex is an oral prescription drug developed by U.K.-based GW Pharmaceuticals PLC. It was formulated to treat two severe types of epilepsy in patients over two years old. These two rare forms of epilepsy are Dravet syndrome and Lennox-Gastaut syndrome, both characterized by frequent and hard-to-treat seizures.
Epidiolex contains highly purified CBD (cannabidiol), which is a non-psychoactive chemical compound found in cannabis. This means that CBD — and therefore Epidiolex — does not create a high among users.
However, the FDA’s approval alone is not enough to put the medication on the shelves. For the drug to be readily available to sick patients, the DEA first needs to reschedule CBD or grant Epidiolex a separate classification status altogether.
CBD was classified by the DEA as a Schedule I substance. Schedule I drugs are not considered to have any accepted therapeutic benefits and are deemed to have a high potential for abuse.
The DEA’s scheduling of Epidiolex was expected within 90 days of the FDA’s approval of the medication.
What does a Schedule V status mean?
According to the Office of the Federal Registrar, the DEA granted Epidiolex a Schedule V status under the Schedule of Controlled Substances.
According to the DEA, Schedule V drugs, chemicals, or substances have a lower potential for abuse than the Schedule IV drugs. These drugs consist of preparations that contain limited amounts of certain narcotics. Schedule V drugs are used generally for antitussive, analgesic, and antidiarrheal purposes.
According to a previous CannabizDaily report, GW Pharma has revealed that Epidiolex would cost an average of $32,000 per patient per year.
GW Pharma’s CEO Justin Gover said that this price is in line with the pricing for other brand-name anti-epilepsy drugs. Gover said that the company wanted to make sure that they price the CBD-based medication in such a way that the means to access it is going to be consistent with that of other branded epilepsy drugs that are already being used by patients.
What’s more, Julian Gangolli, who heads GW Pharma’s U.S. commercialization efforts, the price point for Epidiolex is largely based on the feedback from insurance companies. He also pointed out that their price point is even on the lower end of the price projected by analysts two years ago. Analysts estimated Epidiolex to cost $30,000 to $60,000 per year.