USA approves first marijuana plant-derived drug for epilepsy

Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds. 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.

The FDA previously cleared medications containing synthetic versions of THC for nausea for patients getting chemotherapy and for other uses, but it had not approved any drug derived from the plant itself.

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.

The FDA notes that it will still "take action" against illegal CBD products making "serious, unproven medical claims".

"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. But then Hendershot learned about a trial of Epidiolex at New York University.

CBD oil is now sold online and in specialty shops across the USA, though its legal status remains murky.

Epidiolex won't require a special certification to prescribe, Patel said, and it's likely physicians will prescribe it for off-label uses. The move could open the doors to other marijuana-derived medications as well as ease heavy restrictions on marijuana-related research.

"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.

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Patel helped run trials here testing Epidiolex to treat Dravet syndrome and Lennox-Gastaut syndrome, two rare, often drug-resistant forms of epilepsy that start in childhood.

For a maligned substance like cannabis, I think the vindication tour will ultimately be years long.

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

Epidiolex, manufactured by GW Pharmaceuticals in the United Kingdom, is made from cannabidiol, the non-psychoactive part of the cannabis plant.

The drug should provide a more reliable alternative than the homemade cannabis oil parents for years have made for the children, said Devinsky, who once treated Vivian Wilson of Scotch Plains, a toddler with Dravet syndrome.

Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).

In some cases, patients have moved to states that have legalized medical marijuana in order to have access to the drug. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.

The European Medical Society is also considering approval of Epidiolex and is expected to announce a decision in the first quarter of next year, according to Gover.

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