In April 2015, the Governor of Idaho authorized the establishment of an FDA-approved Epidiolex® Expanded Access program for treatment-resistant epilepsy in children. Executive Order 2015-03 directed the Department of Health and Welfare to implement and oversee the program.
The FDA allowed GW Pharmaceuticals, the manufacturer of the purified cannabidiol (CBD) oil Epidiolex®, to initiate Expanded Access Programs (EAP) to facilitate access to Epidiolex®, which was an investigational drug under evaluation for patients with severe epilepsy not responding to current treatments and who lack therapeutic alternatives.
The Idaho’s Epidiolex® Expanded Access Program was created to:
EAP in Idaho
The neurologist and clinical researcher conducting the Epidiolex® clinical trials partnered with the State of Idaho to initiate an Expanded Access Program for Idaho’s children with intractable epilepsy.
The Expanded Access Program was in addition to a multi-site clinical trial. The EAP began in 2015 and is now complete.
Costs for the EAP resulted from FDA requirements that a specific protocol be followed, including patient visits at specified intervals, certain tests, data collection, and reporting that needed to be funded.
Epidiolex® was approved by the FDA in June 2018, and the drug is now available by prescription. The children have been transitioned to their regular source of care.
Got feedback about our website? Help us make it better by completing a survey. It'll only take a couple of minutes.