FDA grants first approval of a cannabis-derived medicine

Epidiolex a medicine made from the marijuana plant but without THC

"This is clearly a breakthrough drug for an terrible disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.

Epidiolex's effectiveness was studied in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, comparing Epidiolex to a placebo. And Epidiolex could well be the first in a wave of marijuana-based therapies; agency officials said they have implemented regulatory processes to help drug developers test marijuana or its components in their own clinical trials.

Elizabeth Thiele, director of the paediatric epilepsy programme at Massachusetts General Hospital, professor or neurology at Harvard Medical School and a lead investigator in the Epidiolex clinical programme, said: "LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy". However, Schultz says his company plans to create more CBD medications.

According to the FDA, Epidiolex reduced cases of seizures when taken in combination with older drugs used for epilepsy treatment.

Once the DEA gets the FDA recommendation for how CBD should be scheduled, it has 90 days to decide.

Several states have legalized CBD oil for specific treatment of epilepsy or seizure disorders, but with this FDA approval of the compound, it will open up a new treatment option for patients who have struggled with mediating their symptoms.

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"My biggest fear is that they will shut down places like CW Hemp or other companies in legal states that are producing and distributing high quality hemp products to people", Gaer said. The drug, Epidiolex, is meant to treat seizures resulting from Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy.

"It's an unbelievable plant with so many different chemical compounds that can fix medical problems", Defran said.

The drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the US financial markets.

There is a form of CBD available at dispensaries in Texas but it is not covered by insurance.

He said, "Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases". The new drug is anticipated to become available to patients later this fall.

Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of the cannabis plant.

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