FDA Considers Marijuana-Derived Drug For Severe Epilepsy

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The Food and Drug Administration is on the verge of potentially making its first approval of medicine made from marijuana. It could be a game-changer for some patients diagnosed with two devastating forms of epilepsy.

The seizures started when Margot Curtis was just a toddler, and over time, her mom, Carey Stokes-Curtis, says they happened more often and became more severe.

“Grand mal seizures, seizures at night. She wasn’t sleeping. All of a sudden, she would just start screaming and having convulsive seizures,” said Stokes-Curtis.

The seizure activity was so extreme, Margot couldn’t learn basic skills, and the medications she was taking didn’t do enough.

“They weren’t controlling the seizures,” said Stokes-Curtis.

Two years ago, Margot was diagnosed with Lennox-Gastaut syndrome. It’s a severe type of epilepsy that’s been hard to treat.

But a drug called Epidiolex shows promise in clinical trials. It’s an oil made with cannabidiol, a component of the marijuana plant that does not make people high.

Dr. Elizabeth Thiele, director of the pediatric epilepsy program at Massachusetts General Hospital, was the lead investigator in an Epidiolex trial for patients with Lennox-Gastaut syndrome. Her team found an almost 44 percent drop in monthly seizures in patients receiving Epidiolex.

“That’s significant. If a parent could tell you, ‘My child was having 20 seizures a day,’ (and) if you could knock it down 44 percent, even though they weren’t yet seizure-free, that would likely be the best seizure control they’ve ever had,” Thiele said.

Researchers aren’t sure yet how it works and said people need to know it doesn’t work for everyone.

“This is not a silver bullet for epilepsy. That’s true of all the treatments we have. All of the medications that have become available while I’ve been doing this work for some kids, but not for all,” Thiele said.

Now a teenager, Curtis was accepted into the trial two years ago. Her mother noticed a difference after her first dose.

“Left the hospital, didn’t see any seizures after that night (or) the next day (or) the next day. She was seizure-free for over three months,” Stokes-Curtis said.

Margot takes the CBD oil twice a day and has made huge strides. She goes to school and she loves to swim; however, the sweetest change for her mother is the return of her smiles and laughter.

Last month, an expert panel recommended approving Epidiolex. The FDA’s decision is expected next month. If approved, the drug could be used to treat both Lennox-Gaustat syndrome and Dravet syndrome, another devastating form of childhood epilepsy.

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