FDA-Approved Cannabis-Derived Drug for Seizures

Epidiolex — the only cannabis-derived drug product approved by the U.S. Food and Drug Administration (FDA) — has been shown to be effective in reducing the frequency of seizures in patients 1 year and older with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS).

Both are rare forms of epilepsy that start in childhood and are characterized by frequent, prolonged seizures.

“Epidiolex is a very important part of the overall anti-seizure medication armamentarium — especially for patients with Dravet syndrome and Lennox-Gastaut syndrome, both very severe epilepsies with somewhat limited choices of treatments,” says Sudha Kilaru Kessler, MD, a pediatric neurologist in the division of neurology and the program director for both the Child Neurology Residency and the Pediatric Epilepsy Fellowship at Children’s Hospital of Philadelphia.

Two years after green-lighting the product for Lennox-Gastaut and Dravet syndromes in 2018, the FDA also granted a second approval of the drug for the treatment of seizures associated with tuberous sclerosis complex (TSC), a rare genetic disease that causes noncancerous (benign) tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin.

As many as 90 percent of people with tuberous sclerosis complex also have epilepsy.

How Effective Is Epidiolex?

In a study published in 2022 that involved nearly 900 participants with treatment-resistant epilepsies, researchers found that the use of Epidiolex was linked to a 50 to 67 percent reduction in the frequency of average monthly convulsive seizures.

Both Lennox-Gastaut syndrome and Dravet syndrome are “refractory” forms of epilepsy, meaning medicines don’t work well to control attacks, and patients are less likely to be seizure-free even after trying multiple medications.

“In my personal experience, Epidiolex is not a cure or a miracle drug, but it has been very helpful in some patients for a while,” says Dr. Kessler. “It doesn’t make the problem go away, but it can keep seizures from happening when you’re on it.”

She warns, however, that the efficacy of Epidiolex, as with many anti-seizure medications, may wear off a bit over time.

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