US health regulators approve seizure drug made from marijuana

US health regulators approve seizure drug made from marijuana

US health regulators approve seizure drug made from marijuana

Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA.

An FDA advisory committee in April had recommended unanimously that Epidiolex be approved.

"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said.

Epidiolex, manufactured by GW Pharmaceuticals in the United Kingdom, is made from cannabidiol, the non-psychoactive part of the cannabis plant. The agency is expected to do so within 90 days. "Epidiolex has been studied and proven to significantly reduce seizures so, in a few short months, it will be a new and welcome product for doctors to consider for their patients in need".

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"I don't know a mom or dad in their right mind who is going to change what's already working", said Heather Jackson, CEO of Realm of Caring, a charitable group affiliated with Colorado-based CW Hemp, one of nation's largest CBD companies.

The drug, Epidiolex, will be used to treat seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. We've known for years that cannabidiol is a powerful cannabinoid with legitimate and proven medical properties. Epidiolex's approval also marks the first time the FDA has approved a drug to treat Dravet syndrome.

Epidiolex contains cannabidiol, one of the chemicals found in marijuana, however, it will not produce a high that is commonly seen in THC.

Some physicians have expressed relief to finally have an FDA-regulated cannabis-based medication on the market. The drugs are listed as Schedule II and Schedule III, meaning they have medicinal value but also potential for abuse.

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The approval could spur more research into marijuana products, though marijuana itself remains illegal.

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.

"Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes", Gottlieb said.

"Clinical development for these rare and severe conditions is essential, and today's news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures". And, as NPR has reported, CBD supplements are available widely online and in dispensaries in the form of oils or tinctures. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits", Gottlieb said. Rescheduling cannabidiol paves the way for other advanced cannabinoid formulations, like the ones now being researched and developed by scientists on staff at my Colorado-based cannabinoid science business, ebbu.

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