The FDA's decision directly contradicts the decision by the Drug Enforcement Administration to keep the newly approved compound, cannabidiol, under the umbrella of marijuana as a Schedule I substance, since by definition drugs in that class have no medicinal benefit.
The U.S. Food and Drug Administration has approved a marijuana-deriveddrug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood.
The component in this newly approved drug is CBD (cannabidiol), which is part of the sativa marijuana plant. Where is weed legal?
"Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients", FDA Commissioner Scott Gottlieb, said in a statement today.
There are likely to be drug interactions, she said, but "that's not uncommon for antiepileptic medications", and she noted that this could affect the effectiveness of the medication.
Cannabidiol (Epidiolex), an oral solution to treat seizures in Lennox-Gastaut Syndrome (LGS) and Dravet syndrome, was approved for patients two years of age and older. But then Hendershot learned about a trial of Epidiolex at New York University.
In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for. What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research. It comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC, the component that does make people high. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters.
According to Dr. Angel Hernandez, of the Helen DeVos Children's Hospital in Grand Rapids, Mich., these results prove that pharmaceutical-grade CBD helps suppress seizures and "increases our options to treat many of these patients with very, very difficult-to-control epilepsies".
The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals.
It's not clear how quickly the drug will be available for prescription.
Many parents already are giving children unregulated CBD formulations that are available in medical marijuana dispensaries in the many states where such operations are legal. This status has stifled rigorous research, because the federal government will not pay for it. "We want the whole-plant extracts that our kids are using and that have worked for them for years".
GW said it expects the reclassifying to occur within 90 days.
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. European approval is expected in early 2019.