FDA Approves First Marijuana-Based Drug for Epilepsy

By M. Russo — Published June 26, 2018

FDA Approves First Marijuana-Based Drug for Epilepsy

The U.S. Food and Drug Administration announced on Monday the approval of the marijuana-based drug Epidolex (cannabidol) for epilepsy treatment. This is the first prescription cannabis-based medicine to be approved by the FDA.

Epidolex is an oral solution that will be used to treat seizures specifically associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome. It will be available for patients ages two years and older. While this drug is derived from cannabis, it does not contain THC, thus won't provide the "high" that recreational marijuana users value. The most common side effect of Epidolex is sleepiness.

This is the first FDA-approved medication for the treatment of Dravet syndrome. Dravet syndrome is thought to affect between 1 in 20,000 to 1 in 40,000 people and can cause seizures when the individual is in warm temperatures, has a fever, or even when taking a warm bath. In children, emotional stress or excitement can also trigger the seizures. LGS affects 26 out of 100,000 people and tends to be difficult to control as they suffer from a number of different types of seizures. With both of these seizure disorders, after onset of seizures children begin to experience developmental delays. Epidolex has been shown to not only reduce seizures, but to also return some children to near-normal functioning.

source: web images

Philip Gattone, the President and CEO of the Epilepsy Foundation, says that "Epidolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death."

FDA Commissioner Dr. Scott Gottlieb was quick to issue a statement that approval of this medication does not mean that marijuana is approved in general. "This is a purified form of CBD [cannabidiol]. It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits."

Currently, a clinical trial is underway for use Epidolex in the treatment of a third seizure-related condition called tuberous sclerosis complex. Pending the results, Epidolex may be approved for use in this condition as well.  The European Medical Society is considering approval of Epidolex, and will likely announce their decision early next year.

 

 

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