FDA Approves Cannabis-Derived Medicine for the First Time

Epidiolex a medicine made from the marijuana plant but without THC

Epidiolex a medicine made from the marijuana plant but without THC

The U.S. Food and Drug Administration on Monday approved the first cannabis-derived drug for sale, which has shown to control seizures in children with life-threatening forms of epilepsy.

For those who have long argued that cannabis offers medical benefits, the FDA approval represents a milestone, "a recognition that the plant is a rich source of compounds which have potential therapeutic activity", Justin Gover, chief executive of GW Pharmaceuticals, the London-based company that developed the drug, said in an interview last week.

Years ago, the Stanley brothers of southern Colorado grew a strain of marijuana low in THC and high in CBD. The drug, Epidiolex, is meant to treat seizures resulting from Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy.

Most patients with LGS and DS require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs. The FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials.

"This is an important medical advance", he said.

In a statement accompanying Monday's approval announcement, the FDA hastened to note that it's not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use.

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said.

Some have said that they have no intention of switching to the new prescription CBD drug because the products they're using are helping their children.

Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to now approved drugs.

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GW said it expects the reclassification to occur within 90 days.

The FDA has approved several marijuana-based products, including the synthetic formulation Marinol, prescribed to treat severe appetite loss and nausea in conditions such as AIDS.

The Drug Enforcement Administration (DEA) classifies marijuana or cannabis as a Schedule 1 substance - which means there is "no now accepted medical use and a high potential for abuse".

Epidiolex is also the first prescription created to treat children with Dravet syndrome, according to the FDA's announcement.

"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said.

LGS and Dravet syndrome are rare, severe, refractory epilepsy syndromes that emerge early in childhood.

The U.S. approval for Epidiolex was largely expected after an FDA advisory panel endorsed it with a 13-0 vote in April.

As a result, Epidiolex's launch remains at the discretion of the DEA, which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, so as to allow GW to begin selling it.

In 2013, the FDA gave GW Pharmaceuticals of the United Kingdom permission to use the cannabidiol-derived drug, in clinical trials.

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