October 17, 2018

FDA Approves First Drug Derived From Marijuana Plant

26 June 2018, 05:59 | Silvia Roy

FDA Approves First Drug Derived From Marijuana Plant

FDA Approves First Drug Derived From Marijuana Plant

In a news release today, the FDA announced its approval of a marijuana-derived drug called Epidiolex for the treatment of seizures in a subset of patients suffering from severe epilepsy.

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.

The oral solution contains cannabidiol, or CBD, a nonpsychoactive compound that has proved beneficial in reducing the catastrophic, potentially life-threatening seizures that accompany both conditions. Where is weed legal?

Fox hailed Monday's FDA action as a win for the broader medical marijuana community, in that it will facilitate more clinical research into the drug's medical benefits.

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USFDA Commissioner Scott Gottlieb said the approval of the drug was "an important medical advance".

That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained. The drug, Epidiolex, is meant to treat seizures resulting from Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. It is a chemical component of the Cannabis sativa plant and does not cause the intoxication or euphoria that comes from tetrahydrocannabinol (THC).

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. In April, an expert advisory panel for the FDA voted unanimously to recommend Epidiolex's approval and determined that "CBD has a negligible abuse potential".

"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. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

FDA Green Lights Marijuana-Based Pharmaceutical Drug
Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome . The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents.

That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed. The agency is expected to do so within 90 days.

Treatments available for both disorders are far from ideal and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said. Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD. A bill was introduced to the House past year to legalize the use of marijuana, but it has yet to reach the floor for vote.

GW Pharma won't be able to launch the drug right away, however, because its active ingredient, CBD, needs to be rescheduled by the DEA. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances.

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