U.S. approves first marijuana plant-derived drug for epilepsy

U.S. approves first marijuana plant-derived drug for epilepsy

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.

A new drug derived from marijuana just became the first of its kind to get the green light from the U.S. government.

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.

GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD. The medication has been approved for patients aged two years or older and marks the first time the agency has approved a drug derived from cannabis.

"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. However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD. On the other hand, CBD derived from cannabis is a schedule I drug, and only 28 states and Washington, DC have so far legalized it; 15 states have only legalized CBD by itself.

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". But it's not quite medical marijuana.

For now, the easiest thing for consumers to remember is that CBD from hemp is legal while CBD from marijuana is not.

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"I'm really happy we have a product that will be much cleaner and one that I know what it is", said Dr. Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy.

"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.

Epidiolex's effectiveness was studied in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, comparing Epidiolex to a placebo.

FDA's Gottlieb warned about the use of CBD products with "unproven medical claims". "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market.

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