FDA Approves Investigational Trials Assessing Cannabidiol For Pediatric Epilepsy
Washington, DC: The US Food and Drug Administration has approved two clinical trials to assess the efficacy of cannabidiol (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. The cannabidiol formulations in the trials will be provided by British biotechnology firmGW Pharmaceuticals, which produces organic cannabinoid extract medicines, including Sativex. Will doctors throughout the U.S. be called on to submit INDs on behalf of pediatric epilepsy patients whose families want access to Epidiolex™? Interested doctors should direct inquiries to GW’s Associate Medical Director at firstname.lastname@example.org.
Cannabidiol has been documented to possess a variety of therapeutic properties in preclinical models, including anti-epileptic activity. Clinical trials have shown the oral administration of CBD to be “safe and well tolerated” in healthy subjects.
In recent months, several national broadcasts have highlighted the use of CBD-rich oils to treat seizures associated with a pediatric form of intractable epilepsy known as Dravet Syndrome. Read more…