In September 2014, The University of Utah’s Division of Pediatric Neurology and Primary Children’s Medical Center started the first of three clinical trials on the efficacy of Epidiolex, a nonpsychoactive cannabidiol-based drug from GW Pharmaceuticals (NASDAQ: GWPH), in treating intractable epilepsy.
According to Francis Filloux, study author and neurologist, early results show that participants in the clinical trial have experienced a 40 percent decrease in seizure frequency and severity, as reported by The Salt Lake Tribune on April 25, 2016.
With these early results, GW Pharmaceuticals is requesting a meeting with the Food and Drug Administration to address the next step for Epidiolex.
“We believe that the results from our first trial … [are] probably enough for us to file the new drug application,” said Stephen Schultz, a spokesman for GW Pharmaceuticals. Approval for the new drug application could take up to 16 months, Schultz added.
Under House Bill 105, passed in 2014, state residents with intractable epilepsy are permitted to possess hemp extract as a treatment option.
As of Oct. 31, 2015, 113 hemp extract registration cards had been issued, according to the Utah Department of Health.
According to Filloux, the Epidiolex trials should be complete in the next few years.