Sunday, July 21, 2024

Here’s Why The FDA Approval Of Epidiolex Is Significant, According To Dr. Green

The FDA has made a big step forward with the approval of Epidiolex, the first approved medication derived directly from the cannabis plant. This medication was studied in two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. It was found to reduce seizure activity in both syndromes.

The drug had the psychoactive ingredient, THC, removed and is primarily composed of CBD.

This approval is significant for multiple reasons. The most important element is that it gives the patients with these syndromes new hope in controlling their seizures.

Epidiolex has not yet been approved for other forms of epilepsy. But this gives one a pause to think about the possibilities that this drug can hold. In 2015 2.4 million people had epilepsy. Generally, it is thought that 1/3rd of these patients will have refractory seizures; seizures which are not well controlled with medications. Could we now have a new medication to offer these people? This should be studied in the future.

We now have a medication derived directly from the cannabis plant. Now the FDA will have to make a decision as to whether this should be a scheduled Drug. Up to this time, cannabis is a schedule 1 drug, one without any medical benefit. Schedule 1 drugs cannot be prescribed by physicians. They are considered to have a high potential for abuse. We will have to see how the FDA approaches this new category of drugs. I am in the hope that it will either not be scheduled at all (I severely doubt that this will be the case) or will be schedule 3 (the same as Vicodin), schedule 4 (valium) or schedule 5 (cough syrup with codeine). This author certainly does not think CBD has the same abuse potential as Vicodin or valium.

Finally, it is my hope that the acceptance of a cannabis plant derived medication will allow the DEA to rethink its position on cannabis in general and change the schedule to one with a lower risk of abuse. I am also hopeful that we will be able to study cannabis as a treatment for other diseases without being confined by it being a schedule 1 drug.


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