FDA approves first marijuana-based prescription drug

FDA approves first marijuana-based prescription drug

FDA approves first marijuana-based prescription drug

The U.S. FDA approved on Monday the first prescription drug that is made from marijuana.

Yesterday, the U.S. Food and Drug Administration gave the nod to a drug that contains purified canabidiol (CBD), which can be used to treat two rare forms of childhood epilepsy. He described it as the 'first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies'.

"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".

It does not qualify as medical marijuana as CBD is the relaxant chemical compound in cannabis, as opposed to THC, the element of the drugs that induces the feeling of being high.

FDA Commissioner Scott Gottlieb issued a separate statement stressing the importance of proper research on medical uses of marijuana and cautioning other companies that might try to push their pot treatments.

"This is clearly a breakthrough drug for an very bad 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. However, the FDA has found that Epidiolex, when combined with other medications for epilepsy, does reduce seizures.

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Perhaps more importantly, 70 per cent of women disapprove, according to a Quinnipiac University poll taken June 14-17. The UK and Canadian prime ministers, Theresa May and Justin Trudeau, both called it "wrong".

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". And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Last year, the FDA sent warning letters to a number of CBD manufacturers, demanding that they cease making "unproven" claims that their medicines can fight cancer.

GW said it expects the reclassification to occur within 90 days. GW's subsidiary Greenwich Biosciences will market the drug in the US.

Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use.

GW Pharmaceuticals certainly put in the hard yards from a regulatory point of view - Epidiolex's effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients who were suffering either Lennox-Gastaut syndrome or Dravet syndrome.

There is a form of CBD available at dispensaries in Texas but it is not covered by insurance. "This should allow patients to have access to consistent cannabidiol doses made to the highest quality standards".

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