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 directs the Department of Health and Welfare to implement and oversee the program.
The FDA is allowing GW Pharmaceuticals, the manufacturer of the purified cannabidiol (CBD) oil Epidiolex®, to initiate Expanded Access Programs (EAP) in order to facilitate access to Epidiolex®, 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 have partnered with the State of Idaho to initiate an Expanded Access Program for Idaho’s children with intractable epilepsy.
The Expanded Access Program is in addition to a multi-site clinical trial. The EAP enrollment began in 2015 and is now complete.
Costs for the EAP result from FDA requirements that a specific protocol be followed, including patient visits at specified intervals, certain tests, data collection, and reporting, that would need to be funded.
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