Home Markets FDA Makes History As It Approves A Cannabis-based Prescription Medicine

FDA Makes History As It Approves A Cannabis-based Prescription Medicine


While the drive to legalize recreational marijuana is gaining massive countrywide velocity in the U.S., federal authorities now find the science supporting cannabis-based medicines too overwhelming to deny.

That point was made emphatically when, in a history-making move, the U.S. Food and Drug Administration approved the first-ever drug containing an active ingredient derived naturally from cannabis.

The drug, Epidiolex, is now an accepted treatment for two rare and serious childhood epilepsy syndromes; Lennox-Gastaut syndrome and Dravet syndrome.

The exciting new drug contains a compound called cannabidiol or CBD, which is naturally occurring in cannabis. The CBD is purified during Epidiolex’s manufacturing so it can be administered as an oral solution.

Although two other drugs containing synthetic versions of a compound found in cannabis plants have already met FDA approval, Epidiolex is the first drug to be approved that’s made directly from purified medicinal cannabis.

One of the strong points that led to its approval is that Epidiolex doesn’t cause the typical ‘high’ that associated with recreational cannabis use. That because it lacks the psychoactive compound, tetrahydrocannabinol or THC, that gets pot smokers high.

Epidiolex is made and marketed by U.K.-based GW Pharmaceuticals.

Because it is derived from cannabis, which the U.S. Drug Enforcement Agency considers a Schedule I drug, like heroin, Epidiolex is currently labeled as a Schedule I drug like opioids.

But, Stephanie Yip, an analyst at Informa Pharma Intelligence, predicts that within 90 days Epidiolex will be downgraded to Schedule IV or V, which are schedules that include other anti-seizure medications and anxiety drugs. Such as Xanax and Klonopin.

Wide acceptance of CBD-based drugs comes at a time when there’s intense worldwide pressure from parents, patient-advocacy groups, and medical experts to approve cannabis products to control some childhood epilepsy syndromes.

In early June, a British boy, Billy Caldwell, and his mother made worldwide headlines when the medical cannabis they purchased in Canada was seized as they tried to re-enter the U.K.

Young Caldwell suffers from life-threatening seizures. At one time he a legal prescription of a CBD-based oil originally and had been seizure for 250 days

But, British authorities suddenly canceled his prescription for reasons which remain unclear, hence the trip to Canada where CBD is heavily regulated. It’s so regulated, in fact, that most Canadians don’t buy their CBD concentrates from legal sources.

As for the Epidiolex, the FDA approval was a gratifying event for its maker.

“[The] 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,” said Justin Gover, GW Pharmaceutical’s Chief Executive Officer.

GW also markets another cannabis-based drug called Sativex (nabiximols). Its principal active cannabinoid components are THC and CBD. Sativex is an approved treatment in the U.K. for the relief of symptoms in patients with moderate to severe spasticity due to multiple sclerosis.

All in all, it’s an exciting time for medical marijuana and CBD medicine.