AUGUSTA, Ga. (WJBF) - The FDA took a major first step in helping people who suffer from seizures. Almost 50 children with epilepsy in Georgia spent the past two years taking small drops of a new drug by mouth. With improvements in their seizures, an FDA advisory committee gave the green light for the fist pharmaceutical form of plant based treatment.
"Awesome. Totally awesome."
Just three words for this mother, Valerie McCormick, meeting her child for the first time. At 10-years-old, Preston finally has personality.
"This child has been in here all along. But he just couldn't get out, you know? With his brain seizing non-stop, he couldn't get out. And now, his brain has slowed down enough. The seizures have slowed down enough he's able to express himself," McCormick told us.
Preston smiles. He also cries and yells. His mom told us a clinical trial Preston started two and a half years ago is what helped. They are one of 46 families participating in Augusta University's cannabidiol oil trial for people with epilepsy. Now, that oral medicine is closer to helping more people after a Food and Drug Administration advisory committee recently recommended approval of the first prescription drug for Epidiolex. It is manufactured by GW Pharmaceuticals.
AU Health Child Neurologist Dr. Yong Park led the trial at Childrens Hospital of Georgia.
"I was told it would be June," he said of the full FDA approval. "That's what I was told several months ago."
Dr. Park also told NewsChannel 6 majority of the people taking the drug has seen a reduction in seizures. He also said it has proven to be safe.
"It used to be no seizure free days almost every day. But now it skips days," he said.
"I couldn't even begin to count how many he used to have. I would lose count at 30, 40 , 50 a day," McCormick said of her son's epilepsy. "I can count on one hand how many he has now."
Cannabidiol or CDB for short derives from cannabis. The approval would treat seizures caused by Dravet syndrome and Lennox-Gastaut syndrome, which McCormick said her son has. But with the drug set to be approved by the FDA, Preston is finally becoming a normal 10-year-old kid.
"If he's not happy, he lets me know. When he is happy he lets me know. He verbalizes. He laughs. He smiles. If he's not happy, he whines, he cries, he yells out at me," she said.
Approval could come as soon as June. If that happens, Epidiolex would be the first ever FDA approved medicine for Dravet Syndrome patients.
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