FDA Approves Marijuana-Based Drug To Treat Severe Epilepsy

"But it's also important to note that this is not an approval of marijuana or all of its components". The CBD oil derived from the marijuana plant has been administered to relieve insomnia, anxiety and chronic pain, as well as to treat multiple sclerosis and Parkinson's disease, among conditions, wrote Harvard Medical School professor Dr. Peter Grinspoon. But marijuana products in general are subject to Schedule I restrictions by the Drug Enforcement Administration (DEA) because of the potential for abuse.

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.

"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters.

Patel helped run trials here testing Epidiolex to treat Dravet syndrome and Lennox-Gastaut syndrome, two rare, often drug-resistant forms of epilepsy that start in childhood. From Walmart to CVS to the Mom-n-Pop drugstores still kicking it Smalltown, USA - legitimate cannabis medicine will be available in the same way as other prescription drugs. The administration would then presumably reclassify cannabidiol in a less restrictive schedule (the DEA has five drug schedules, with Schedule I being the most restrictive and Schedule V being the least restrictive). "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery".

Patel said the drug trials generated good information about safety and side effects of CBD use, and the FDA approval opens doors for more research on the benefits and effectiveness of CBD on other conditions.

The agency, he added, remains concerned about "the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims".

A mother feeds her epileptic son, whom she treats with medical marijuana, in Siedlce, Poland, in October 2017.


Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day.

The component in this newly approved drug is CBD (cannabidiol), which is part of the sativa marijuana plant. "This is the approval of one specific CBD medication for a specific use", Gottlieb said.

The FDA is not required to follow the advisory panel's advice but usually does.

The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals. "We're the world-leaders in cannabinoid science, and I think we expect to stay there for quite some time".

"This is clearly a breakthrough drug for an bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.

A reclassification is expected within 90 days, according GW Pharmaceuticals.


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