FDA Approves First Cannabis-Derived Drugs
The Food and Drug Administration now approves medical marijuana! On Monday, June 25th, 2018, Epidiolex was approved for treating Lennox-Gastaut syndrome and Dravet syndrome, two rare types of pediatric epilepsy.
The oral solution of Epidiolex contains cannabidiol or CBD, which is a non-psychoactive compound that’s proven to be beneficial in reducing the number of catastrophic, potentially deadly seizures which come with both Lennox-Gastaut and Dravet syndomes.
During the clinical trials, children with Dravet syndrome received Epidiolex and had a reduction in seizures by 39%. Children with Lennox-Gastaut syndrome saw a 37% decrease in the number of seizures.
In a statement released with Monday’s announcement, the Food and Drug Administration added that it is not signing off on the safety or medical utility of marijuana, just this one particular compound and only for the use in treating the two pediatric seizure disorders.
Outcome of Study
The drug will be available to patients all across the U.S., not only limited to states where cannabis is legal for medical reasons.
While there was some initial hesitation about whether the DEA would block the sale of Epidiolex, given cannabis’ status as a schedule I substance, GW Pharmaceuticals, the drugs’ manufacturer doesn’t believe that will happen.
Steve Fox, the director of VS Strategies, retained by GW Pharmaceuticals to handle media and public relations, said, “The DEA will not prevent Epidiolex from being sold. The role of the DEA at this point is to be involved in determining the appropriate schedule for Epidiolex. But as far as I understand it, they don’t even have the power to block it at this point. They just determine what schedule it will be.”
For advocates of medical marijuana, the FDA approval of Epidiolex is a vindication of a decades long movement. Advocates would like to see cannabis be recognized for legitimate medical applications and it isn’t the horrible bad drug the federal government has been lauding it to be.