The FDA’s advisory panel has voted unanimously to recommend the synthetic marijuana drug Epidiolex for approval. Epidiolex, manufactured by G.W. Pharmaceuticals in the United Kingdom, is synthetic CBD that has shown promising results by reducing epileptic seizures by 44%.
The recommendation is not binding, but it is customary for the FDA to follow through with the advisory panel’s recommendations, The Motley Fool reports.
In studies Epidiolex was used to treat participants with Dravet syndrome, a form of intractable epilepsy. Participants saw three times greater decrease in seizures.
There are no FDA-approved medications for Dravet syndrome at this time, and only a few for Lenox-Gastaut syndrome. Those with Lenox-Gastaut syndrome would also be permitted to use Epidiolex if approval is given.
Approval of Epidiolex would be a major milestone in the U.S as it would be the first time that CBD is recognized by the FDA for its medical benefits, even if it is a synthetic form. Approval may also help further fuel efforts to reschedule marijuana, or at least its derivatives, at a federal level.
A formal decision regarding Epidiolex is expected by June 27.
Photo: GW Pharmaceuticals