FDA Likely To Approve Cannabis-Derived Drug Epidiolex For Treatment Of Childhood-Onset Epilepsy

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Treatments for childhood-onset epilepsy are very limited. Children afflicted with the dreaded condition are subjected to numerous and sudden seizures, a heartbreaking and horrifying experience for both patients and parents.

For years, medical researchers have desperately searched for anything that helps reduce or eliminate epilepsy symptoms. Using a substance directly derived from marijuana, British drug maker GW Pharmaceuticals developed a drug several years ago that made a significant breakthrough in the treatment of the disease.

Called Epidiolex, the drug is an oral solution made with cannabidiol (CBD), one of many chemicals in the cannabis plant. The drug has shown in testing to significantly reduce seizures in children with severe forms of epilepsy.

As reported by the Times-Picayune, GW is currently working on getting Epidiolex approved in the United States. Approving the marijuana-derived drug will be a first for the U.S. Food and Drug Administration. While the regulatory agency has greenlighted drugs containing ingredients that mimic chemicals in cannabis, it has never allowed medication made directly from the plant.

Epidiolex approval would mean children with Lennox-Gastaut and Dravet syndromes, two extreme forms of epilepsy, would have access to the drug. Both conditions cause uncontrollable daily seizures which often lead to physical and mental disabilities as well as early death. Approximately 45,000 people in the U.S. suffer from these terrible diseases.

Even though Epidiolex is not yet available in the U.S., many parents are not waiting for the FDA. CBD concoctions are already available at dispensaries in states with legal medical marijuana.

Already aware of the possible seizure-stopping power of CBD, parents, like Heather Jackson in Colorado Springs, Colorado, have been using the treatment with their kids for years. Jackson’s son Zaki, who had been subjected to frequent seizures since he was an infant, was given CBD six years ago when he was 12-years-old. While some minor seizures still occur occasionally, they mostly stopped shortly after treatment began.

Another child, Sam Vogelstein, had nearly 100 seizures a day for years. In 2012 when Sam was 11, his mom took him to visit GW Pharmaceuticals in London. He tried Epidiolex, and the seizures quickly subsided. It was because of Sam that the drug maker decided the medication needed to be available in the U.S.

Sam went before an FDA advisory committee in April to describe his experience before and after taking Epidiolex. After the meeting, the committee unanimously recommended the drug be approved for patients in the U.S.

If the FDA gives Epidiolex final stamp of approval, it will likely encourage other companies to study the potential medical benefits of CBD. Researchers already suspect the cannabis-derived chemical can help with a variety of disorders like anxiety, post-traumatic stress, and Chron’s disease.