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Published: Wed, June 27, 2018
Medical | By Garry George

With CBD, marijuana-based medicine gets its first greenlight from the FDA

With CBD, marijuana-based medicine gets its first greenlight from the FDA

The drug, Epidiolex, is made up of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.

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". Epidiolex, which is produced by the United Kingdom-based company GW Pharmaceuticals, is meant to treat two forms of rare childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

Patients age 2 and up will be able to use the drug. Carreno says that once the drug is descheduled, CBD manufacturers must register with the DEA-and that will make all the difference to the industry in the U.S.

"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". It also marks a landmark moment in the agency's advancement in considering cannabis for medical purposes.

One key takeaway is that other drugs made with CBD now have a clearer path forward for federal approval.

"I hope patients have conversations with their physicians about whether this product (Epidiolex) provides them with treatment they have been looking for with other unapproved products", said Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research.

The FDA is approving this new drug, despite it still being considered a Schedule 1 drug by the Drug Enforcement Agency. Accordingly, before Epidiolex is ready for use amongst patients, it needs to be appropriately reclassified - something GW Pharmaceuticals expects to see happen within the next three months. FDA chief Scott Gottlieb said his agency had supported research on cannabis-derived products "for many years".

Patients, parents of children suffering from severe epilepsy, and some researchers have long suspected CBD's potential to treat the devastating seizure disorders.

But before the medicine can hit the market in those areas, the Drug Enforcement Administration must reclassify marijuana, now a Schedule I drug, along with heroin and Ecstasy, that is described as a substance with "no now accepted medical use and a high potential for abuse".

Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).

An external FDA advisory panel recognized as much when it stated in April that cannabidiol would need to be rescheduled before legal sales of Epidiolex could begin. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. The company is also looking beyond CBD at uses for marijuana compounds that range from neurological conditions to diseases like multiple sclerosis and cancer to other issues like pain.

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