Shaun Hussain, MD, a pediatric neurologist at Ronald Reagan UCLA Medical Center in Santa Monica, says that while the FDA's approval of a marijuana-based drug is "indeed a big deal", it is also significant because "it offers another drug for Lennox-Gastaut and the first-ever drug for Dravet".
"The same principles around any prescription medication can now be applied to cannabis-based medications", GW Pharma Chief Executive Officer Justin Gover said in an interview before the FDA's decision.
Contrary to the misconception CBD does not induce a high as does the other cannabis component TCH.
As a component of the cannabis plant, CBD is considered a Schedule I substance by FDA per the Controlled Substances Act.
But the agency is expected to do just that. What's more likely is that the DEA reschedules CBD, while leaving THC and marijuana itself as a Schedule 1 substance. FDA officials had indicated they supported approving Epidiolex, and an advisory panel had unanimously recommended it get the green light.
The DEA did not immediately respond to Ars' request for comment.
For the record, the approval came nearly after two years of medical trials that the company conducted.
More than 90 percent of patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at constant risk for falls and injury.
Several states have legalized CBD oil specifically for the treatment of intractable epilepsy or seizure disorders.
"I believe if you are a CBD manufacturer and you can say that you're making a quality product, from the farm your product is grown in.to the team that is working to package, bottle, and support the product. then you have nothing to worry about", Harrylall said.
This Washington Post article announces approval by the U.S. Food and Drug Administration of the first drug made directly from a compound found naturally in marijuana plants.
But it's not quite medical marijuana. The FDA has had a dim view until recently of these claims and has made promises to take legal action against companies marketing unregulated CBD products created to treat serious illness, concerned with unapproved products that could discourage patients from seeking other approved therapies for serious or life threatening diseases. Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
FDA commissioner Scott Gottlieb said the drug was an "important medical advance" but cautioned that approval did not cover medicinal cannabis, which is legal in some U.S. states but not in others.
Earlier today, FDA Commissioner Scott Gottlieb made similar observations in a prepared statement. It's an oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy - Lennox-Gastaut syndrome and Dravet syndrome.