First Cannabis-Based Drug For Childhood Epilepsy Approved in USA
Jun 28, 2018, 00:49
Here's how FDA Commissioner Scott Gottliebput it: "It's also important to note that this is not an approval of marijuana or all of its components".
"And, the FDA is committed to this kind of careful scientific research and drug development". When taken with other medications, Epidiolex was shown to be effective in reducing the frequency of seizures in patients compared to those who took a placebo.
Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies...
This one landmark approval could have another one following it soon: the reclassification of CBD by the United States Drug Enforcement Administration. Catherine is part of the drug company's clinical trial.
Because CBD is still a Schedule 1 drug - those with a high potential for abuse and no medical value - GW can not market Epidiolex until the U.S. Drug Enforcement Administration reclassifies it, which is anticipated to occur within 90 days. "This should allow patients to have access to consistent cannabidiol doses made to the highest quality standards". The decision caps decades of work by the company to gain approval in the US for a medicine derived from the cannabis plant. The first is Dravet syndrome, which is a rare genetic dysfunction that starts within a child's first year, and the second is Lennox-Gastaut syndrome, which is a form of epilepsy that causes multiple types of seizures usually starting from 3 to 5 years old.
He said there are thousands of parents with children having daily seizures who want all medical treatments explored, even those involving cannabis.
Epidiolex (cannabidiol) has been tipped as a potential blockbuster and the approval is the culmination of years of trials and development of the drug, which lacks the high associated with marijuana. Although a synthetic version of THC, marijuana's main psychoactive ingredient, has been legally available as a treatment for nausea and appetite loss since 1985, this is the first time the federal government has given its blessing to a medication derived directly from cannabis. The FDA noted, however, that it will still "take action" against the illegal marketing of CBD-containing products with unproven medical claims.
There is a form of CBD available at dispensaries in Texas but it is not covered by insurance.
Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of the cannabis plant.
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