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Fri Oct 25, 2013, 08:00 PM

FDA Approves Investigational Trials Assessing Cannabidiol for Pediatric Epilepsy

It looks like Sanjay Gupta's report on the medical benefits of cannabis for one particular devastating form of epilepsy has helped to fast track a study at the FDA - or at least make their refusal unconscionable.


Oct. 24th -

The US Food and Drug Administration has approved (http://www.beyondthc.com/comes-now-epidiolex-fda-approves-ind-studies-of-cbd/) two clinical trials to assess the efficacy of cannabidiol (http://blog.norml.org/2008/10/09/is-there-anything-cbd-cant-do-then-why-is-it-illegal/) (CBD), a nonpsychoactive plant cannabinoid, in the treatment of intractable pediatric epilepsy. The two approved trials will take place at New York Medical School and at the University of California at San Francisco, according to an online report in the journal O'Shaughnessy's. (http://www.beyondthc.com/about/) The cannabidiol formulations in the trials will be provided by British biotechnology firm GW Pharmaceuticals, (http://www.gwpharm.com/) which produces organic cannabinoid extract medicines, including Sativex.( http://www.gwpharm.com/Sativex.aspx)

Cannabidiol has been documented to possess a variety (http://projectcbd.org/) of therapeutic properties in preclinical models, including anti-epileptic activity. (http://www.ncbi.nlm.nih.gov/pubmed/22696383) Clinical trials have shown the oral administration of CBD to be "safe and well tolerated" (http://blog.norml.org/2012/09/05/study-non-psychotropic-cannabinoid-proven-to-be-safe-in-humans/) in healthy subjects.

In recent months, several national broadcasts have highlighted (http://edition.cnn.com/2013/08/07/health/charlotte-child-medical-marijuana/) the use of CBD-rich oils to treat seizures associated with a pediatric form of intractable epilepsy known as Dravet Syndrome.

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