Cannabidiol Medicine Gets FDA Approval over Severe Epilepsy Treatment

Kathy Young  AP

GW Pharmaceuticals has received a unanimous recommendation from the FDA Advisory Committee Meeting supporting the approval of what could soon be the first cannabinoid-based drug, to treat seizures in two severe forms of epilepsy.

If approved Epidiolex will be the first pharmaceutical formulation of purified, plant-based cannabidiol, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.

Although the committee's decision is not binding, the regulator usually follows the advice of its advisers, and is set to give a final verdict on Epidiolex before a legal deadline of June 27.

Cannabidiol, also called CBD, does not produce a high, unlike tetrahydrocannabinol, or THC.

'I think it needs to be approved because everyone is using it across the internet without knowing the safety and no one is watching the interactions with other drugs, ' Dr Conry, from Children's National Health System in Washington, told AP.

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If the drug is approved for epilepsy, Epidiolex, would need to be prescribed "off-label" for other uses.

"Although CBD is a cannabinoid, it shares nearly none of the pharmacologic features of the prototypical cannabinoid", the FDA committee staff wrote, noting that the drug "has significantly less abuse potential" than two other forms of cannabis: THC given as 2 doses of dronabinol or a single dose of alprazola, or ALZ.

The drug, Epidiolex, carries a risk of liver damage, but the panel said that doctors would be able to monitor their patients for any changes. CMD contains less than 0.1 percent of THC.

While the panel of experts who met Thursday determined the drug "appears to support approval", they were concerned about the potential side effects, which include diarrhea, vomiting, fatigue and sleep problems.

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