GW Pharmaceuticals

Epidiolex Receives Initial Recommendation from FDA Committee

Epidiolex, a CBD-based pharmaceutical medication created by GW Pharmaceuticals in the United Kingdom, has received a unanimous recommendation from an FDA advisory committee. The committee’s recommendation sets Epidiolex up to potentially receive FDA approval for U.S. distribution by June, CNN reports.

According to GW’s website, Epidiolex is a “proprietary oral solution of pure plant-derived cannabidiol.” It was developed to treat epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex, and Infantile Spasms. If approved, it will be the first cannabidiol-based medication available for prescription use in the U.S.

“We’re obviously very pleased by the unanimous recommendation in support of the approval of Epidiolex. It’s a very important milestone in the approval process.” — Justin Gover, CEO of GW Pharmaceuticals

Pharmacist Shauna Garris told CNN that she’s not sure whether Epidiolex will live up to the “publicity” and “hype” surrounding the product, but that the medication is working somewhere between “fairly” and “very well.” In the report, Garris warned that “There have been side effects associated with it, and it appears a lot of the side effects were in conjunction with other medications.”

Philip Gattone, president and CEO of the Epilepsy Foundation, told NBC News, “Epidiolex 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.”

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