FDA Committee Recommends GW's Cannabis-Based Seizure Drug
GW Pharmaceuticals Plc's cannabis-based drug to treat a severe form of childhood epilepsy was unanimously backed on Thursday by an advisory panel to the U.S. Food and Drug Administration.
The drug, Epidiolex, would be administered in a syrup form and is made from a purified ingredient in cannabis called cannabidiol, or CBD. GW Pharma uses a plant bred to have high cannabidiol, or CBD, content to make the drug, Chief Executive Officer Justin Gover said in an interview earlier this month. It has less than 0.1 percent THC, and is now being considered to treat Dravet syndrome and Lennox-Gastaut syndrome, two very rare and usually untreatable forms of childhood epilepsy.
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).
Tuesday's announcement and today's meeting could precede an FDA decision to allow Epidiolex to be marketed and sold in the United States as soon as June 27, according to Bloomberg.
The FDA does not have to act on the recommendations of its experts, but typically does.
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"This is clearly a breakthrough drug for an bad disease", said Dr. John Mendelson, a panel member and senior research scientist at Friends Research Institute.
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. In the briefing documents, the FDA officials wrote that the "risk of liver injury has the potential to be serious", but that it could be addressed by tracking liver function during treatment.
"CBD is now a Schedule I drug", the FDA notes, while simultaneously admitting, in a memo attached as an appendix, that "CBD does not appear to have abuse potential".
Participants in one study experienced a 38.4 percent reduction in seizure frequency over a 28-day period with a 20 milligrams per day dose of CBD, as per the report, which also found no evidence to suggest that the drug could be abused or create a dependency. But since Olivia began taking Epidiolex in 2014, her mother said, there have been "great improvements", including many days when she did not have any seizures at all. Ahead of Thursday's advisory committee review, shares of GW Pharma were up about 7 percent this week.
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