FDA Approves First Marijuana-Based Drug

Simon Moss
June 28, 2018

This two-phase trial has proved to be highly effective in treating children detected with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) - two severe and rare forms of epilepsy, for the patients aged 2 years and above.

The U.S. Food and Drug Administration (FDA) gave its final approval to GW Pharmaceuticals' Epidiolex medication on Monday, completing a lengthy trial and review process.

"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", said Justin Gover, GW's Chief Executive Officer.

This bit of marijuana news marks the first time in the history of the US that the FDA has given its approval to a purified drug derived from marijuana.

Epidiolex, manufactured by GW Pharmaceuticals', contains cannabidiol, or CBD, which is a component of marijuana that does not produce a strong psychoactive effect on the users and make them feel high. Outside the US, this medicine is now under review by the European Medicines Agency (EMA) for the treatment of seizures associated with Dravet Syndrome and LGS.

Epidiolex is made of CBD (cannabidiol), a cannabis chemical compound of marijuana that does not cause tightness.

The drug is an oral solution derived from cannabis. "These patient populations desperately need new treatment options to help control their seizures and the results of the clinical trial in both disorders are very promising".

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Currently, CBD is still a Schedule I substance, meaning it is classified as a substance that has a high potential for abuse and no medical applications.

Here's how FDA Commissioner Scott Gottlieb put it: "It's also important to note that this is not an approval of marijuana or all of its components". The company's development program represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with LGS and Dravet Syndrome.

The FDA's approval, and the subsequent expectation that CBD will be rescheduled by the DEA, is good news for the fledgling cannabis industry.

FDA's Gottlieb warned about the use of CBD products with "unproven medical claims".

For now, companies in states where marijuana or CBD is legal have the freedom to continue selling their products with little federal oversight while they benefit from the increased attention and legitimacy that Epidiolex's approval lends them.

"It's time that we start taking a look at the marijuana plant, the cannabis derivative, and trying to find medical uses for it", he said to Maria Bartiromo on "Mornings with Maria". As noted in the FDA's announcement approving Epidiolex, "m$3 arketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

But he said that won't affect Epidiolex's approval, since individual drugs often receive their own schedule.

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