US OKs marijuana-based prescription drug for seizures

Epidiolex a medicine made from the marijuana plant but without THC

Epidiolex a medicine made from the marijuana plant but without THC

The FDA says this is the first drug of its kind approved in the USA that contains a purified substance derived from the cannabis plant.

The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older.

The move marks several firsts.

The good marijuana news for GWPH is that the organization is giving its approval to Epidiolex.

Indiana's Attorney General is praising the FDA for approving a first of it's kind drug.

Here's how FDA Commissioner Scott Gottlieb put it: "It's also important to note that this is not an approval of marijuana or all of its components".

"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", Gottlieb added.

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".

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The medication, tested in three randomized, placebo-controlled trials with more than 500 patients, was effective in reducing seizures, the FDA said.

The decision follows a unanimous vote in favour of the approval by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee.

The Drug Enforcement Administration must reclassify cannabidiol before GW Pharma can market Epidiolex.

Philip Gattone president and chief executive of the US-based Epilepsy Foundation said, "For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement". Common side effects include sleepiness, elevated liver enzymes, decreased appetite, diarrhea, rash, and weakness.

The drug is a syrup with a strawberry flavor, containing a purified form of a chemical found in the cannabis plant, cannabidiol (CBD). "The conditions it is approved to treat are devastating and hard to control and so rightly got the attention of pharmaceutical companies and regulatory agencies", he says. It does not contain THC, the well-known psychoactive component of marijuana responsible for the drug's characteristic high. "These patient populations desperately need new treatment options to help control their seizures and the results of the clinical trial in both disorders are very promising".

The company has not announced pricing for the drug, but Wall Street analysts previously predicted it could cost as much as $25,000 per year.

Reclassification of CBD could set the stage for the approval of other cannabis-derived medications. "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

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