Thursday, 18 October, 2018

GW’s cannabis-based Epilepsy drug to receive U.S. FDA approval

Epidiolex a medicine made from the marijuana plant but without THC FDA approves first ever drug derived from marijuana | TheHill
Delia Stanley | 28 June, 2018, 11:23

In a historic move, the US Food and Drug Administration has given the green light for the drug's use to treat seizures associated with Lennox-Gastaut Syndrome or Dravet Syndrome, two rare, severe and notoriously difficult-to-treat childhood-onset epilepsies.

Made by GW Pharmaceuticals, the drug treats two rare types of epilepsy using CBD, a therapeutic compound in cannabis that's not linked with a high. Earlier this year, an expert advisory panel for the FDA voted unanimously to recommend Epidiolex's approval and stated that "CBD has a negligible abuse potential".

The chemical used in Epidiolex, cannabidiol, is a component of the cannabis sativa plant, but does not carry the same psychoactive effects or "the high" that results from pure tetrahydrocannabinol (THC) consumption. It's the first-ever FDA-approved drug treatment for the Dravet syndrome.

The approval was granted to Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals, for Epidiolex, an oral solution of purified cannabidiol (CBD).

The article does note that parents are giving their affected children "unregulated" CBD formulations, and although there are also other drug treatments and (although of unproven value) some efforts at surgery to abate the seizures, these offer less than good solutions, as the article notes.

This is the first FDA-approved drug that contains the marijuana-based purified drug. "As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks", FDA said. The FDA noted in its announcement today that it informs and advises the DEA about scheduled substances.

Sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise, weakness, insomnia, sleep disorder, poor quality sleep, and infections were among the most common adverse effects seen with Epidiolex treatment. "And, the FDA is committed to this kind of careful scientific research and drug development", said FDA Commissioner Scott Gottlieb. However, with Epidiolex, patients will be able to get a high-grade, medically regulated dosage each time they take it.

This one landmark approval could have another one following it soon: the reclassification of CBD by the United States Drug Enforcement Administration.

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.

"This is an important medical advance", Gottlieb said. "This decision by the FDA puts another tool in the toolbox to treat people with Angelman syndrome". The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans. Finally, FDA granted orphan drug designation for Epidiolex for both Dravet and Lennox-Gastaut syndrome indications.

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