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August 19, 2018

Expanded Access Program

Expanded Access Program (EAP) for Treatment-Resistant Epilepsy in Children

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:  

  1. Treat children with intractable epilepsy 0 through 18 who do not respond to standard medications with a drug that has met FDA requirements for safety in preclinical research while clinical trials take place, and  
  2. Gather preliminary information for phased trials that will determine whether Epidiolex® can reduce epileptic seizures more effectively than standard medications.

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.  

 

Questions?

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