FDA Approves First Prescription Medication Made From Marijuana

Nora Nguyen
June 28, 2018

The FDA commissioner said the "path that made this possible" is "a path that's available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs".

Anup Patel, M.D., chair of the LGS Foundation's professional advisory board, chief of neurology at Nationwide Children's Hospital and study investigator, says, "I am very pleased to see the FDA's approval of EPIDIOLEX® for LGS and Dravet syndromes". When taken with other medications, Epidiolex was shown to be effective in reducing the frequency of seizures in patients compared to those who took a placebo. "In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition".

Epidiolex is created to treat two rare forms of childhood epilepsy.

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

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Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy.

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.

Cannabidiol (CBD) is one of the most abundant compounds in the marijuana plant.

Federal agencies have 90 days to determine the scheduling of Epidiolex.

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We've just got to accept whatever decisions are given by the referee on the field or the VAR officials. So, we're not going to be wildly different to that", he said.

The approval was granted to Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals, for Epidiolex, an oral solution of purified cannabidiol (CBD). CBD does not contain THC, the psychoactive ingredient in marijuana, so it can not get patients high. "This should allow patients to have access to consistent cannabidiol doses made to the highest quality standards".

The agency, he added, remains concerned about "the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims".

Many parents already are giving children unregulated CBD formulations that are available in medical marijuana dispensaries in the many states where such operations are legal.

The FDA's decision will give renewed hope to the makers of other CBD products that they may be able to get theirs over the line for these and other conditions. 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.

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Do you think many more marijuana-based drugs will follow Epidiolex?

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