First Cannabis-Derived Drug Nears FDA Approval

An advisory panel to the FDA votes in favor of approval of GW Pharma’s Epidiolex. The seizure drug would be the first FDA-approved use of cannabidiol (CBD).

An advisory panel to the FDA votes in favor of approval of GW Pharma’s Epidiolex. The seizure drug would be the first FDA-approved use of cannabidiol (CBD).
An advisory panel to the FDA votes in favor of approval of GW Pharma’s Epidiolex. The seizure drug would be the first FDA-approved use of cannabidiol (CBD).

An outside advisory panel to the FDA voted unanimously in favor of approving the first cannabis-based drug in the U.S., GW Pharma’s Epidiolex. The drug is intended for treatment of seizures, with cannabidiol (CBD) as its active ingredient. With less than 0.1% THC, the drug does not have a psychoactive component.

Reuters reports that the 13-person panel found “that the drug’s benefits outweighed the risks to treat patients aged 2 years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.”

A synthetic form of THC, FDA-approved Marinol, has been on the market for years as an appetite stimulant or antiemetic (to prevent vomiting or nausea).

While the panel’s vote does not guarantee FDA approval of Epidiolex, it is positive sign for patients who benefit from cannabis-based treatment. The FDA is expected to issue a decision by June 27, 2018.

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