27 June, 2018
While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case.
Dr. Anup Patel, neurology section chief at Nationwide Children's Hospital in Columbus, said Monday's announcement is good news for epilepsy patients who have been waiting for relief from the state's 2016 medical marijuana law or have been experimenting with unregulated products claiming to contain CBD.
The drug contains nearly non of the psychoactive chemical from marijuana that makes people high and proved through testing to be effective in treatment of certain pediatric seizure patients.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", FDA Commissioner Scott Gottlieb said. It also marks a landmark moment in the agency's advancement in considering cannabis for medical purposes.
Aside from Epidiolex, GW Pharma also sells Sativex-which includes components of marijuana-in 30 countries as a treatment for multiple sclerosis-related spasticity. This is the approval of one specific CBD medication for a specific use.
This means Epidiolex, which will require a prescription from a doctor, will soon be available in pharmacies all across the nation. There are only a few pharmaceutical treatments for patients living with Lennox-Gastaut, no pharmaceutical options for those living with Dravet syndrome. The DEA's decision is expected to be made within 90 days.
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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.
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 reschedule should make it easier for researchers to study CBD for its potential health benefits.
The FDA news signals that the DEA will likely adjust its scheduling for CBD, which is now a Schedule I substance, denoting high potential for abuse and no medical applications.
Ironically, an advisory panel for the FDA unanimously approved the recommendation for Epidiolex one day before 4/20.
The FDA's decision was not unexpected, as the proprietary extract formulation - developed by the British biotechnology firm GW Pharmaceuticals - had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. 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).