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August 21, 2017

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.  

Once created, Idaho’s Epidiolex® Expanded Access Program will:  

  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 will partner 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 clinical trial that will be occurring nationwide this year. The EAP is expected to begin enrolling patients during summer or fall of 2015.

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.  

The cost of the program is expected to be $223,500 to serve 25 children this fiscal year.

 

Questions?

The Expanded Access Program is still in the early phases of development, and more information will be forthcoming. Check back for updates, or click on the “Contact Us” button if you have specific questions.

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