Epidiolex(R) by GW Pharmaceuticals approved to treat 125 epileptic children

British pharmaceutical company GW Pharmaceuticals has announced the US Food and Drug Administration’s (FDA) approval of its new drug Epidiolex(R), which the company describes as an “oral liquid formulation of a highly purified extract of CBD.” The approval came under the auspices of the FDA’s “orphan drug” program, which affords tax breaks and other incentives to pharmaceutical companies which develop drugs to treat rare disorders or other conditions which would not normally offer a high return on research dollars. Two synthetic THC pills, dronabinol and nabilone, have already been approved.

The company says that it will begin a clinical development program to treat child patients with Dravet syndrome, a rare form of epilepsy which is resistant to standard anti-seizure medications, in 2014. However, pediatric epilepsy specialists may start distributing the drug to children even sooner, under seven new Investigational New Drug (IND) approvals granted by the FDA this year. Dravet syndrome was featured prominently in Sanjay Gupta’s documentary “Weed,” which aired in August, and has morphed into a kind of morbid poster child for the litany of diseases effectively treated by cannabis.

CBD, short for ‘cannabidiol,’ is a naturally occurring plant-based cannabinoid which has been found to complement the medicinal effects of THC while mitigating its intoxicational effects. New research has shown the cannabinoid to potentially have powerful medical benefits in its own right, a possibility contemplated by the newly-approved trials to test its efficacy for children with severe epileptic symptoms. – West Coast Leaf News Service

 

 

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Pediatric epilepsy specialists may start distributing the drug to children even sooner, under seven new Investigational New Drug (IND) approvals granted by the FDA this year.