Epidiolex a medicine made from the marijuana plant but without THC
21 April, 2018, 06:18
If the FDA as a whole decides to follow the panel recommendation, then the syrup from GW Pharmaceuticals would take the honor of being the first federally approved cannibis-based drug in the U.S.
GW Pharmaceuticals makes its drug from cannabis plants that are specially bred to contain high levels of CBD. Experts believe the drug reduces seizures in children with two rare forms of severe epilepsy.
If approved, it would be the first drug derived directly from the cannabis plant to get approval in the U.S.
The larger implications for cannabis-based drugs are less clear, and researchers were measured about this opening the floodgates because of US restrictions on researching the compounds, as well as other illegal drugs that might have medical uses. FDA staff were also positive on the treatment, saying in a report ahead of the meeting that the United Kingdom -based drugmaker provided "substantial evidence" of Epidiolex's effectiveness. The next event for GW Pharma is June 27 which is the goal date for PDUFA (Prescription Drug User Fee Act) completion of the NDA review of the cannabidiol oral solution and if approved, the medicine is expected to be available by prescription in the second half of 2018.
The Food and Drug Administration's approval would technically limit the treatment to a small group of epilepsy patients. Currently, CBD is sold in both medical and recreational marijuana markets across the country, including a hemp derivative that can be found in health food stores outside of legal weed states.
The drug carries a potential risk of liver damage, but panelists said doctors could monitor patients for any signs. Epidiolex was designed especially for severe, early-onset epilepsy syndromes like Dravet syndrome and Lennox-Gastaut syndrome. "The results from these studies suggest that this pharmaceutical formulation of cannabidiol may provide hope for a new treatment option that may be effective for some patients".
Since naturally-occuring CBD has far fewer side effects than most synthetically-produced pharmaceuticals, Epidiolex trials have included patients as young as three years old.
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