Expanded Access Program

At Zogenix, we are committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases.

We believe the optimal approach to bring an approved therapy to the community is by creating clinical development programs designed with input from experts in the medical community, regulatory authorities and the patient community. Our goal is to quickly enroll eligible patients into clinical studies in order to demonstrate the safety and effectiveness of our investigational products, and to rapidly obtain the global regulatory approvals needed to make these therapies widely available to patients that need them around the world.

The primary preferred mechanism for access to investigational therapies is by participation in one of our clinical studies.  However, we recognize that all patients may not be able to take part in our clinical trials and face urgent medical need.  As a result we offer a limited expanded access program (also known as “compassionate use” or “early access”) for our investigational therapy ZX008.
When a request for expanded access to our investigational therapy is made outside of a clinical trial, we carefully consider each request based on the following criteria:

  • Scientific rationale for a possible therapeutic benefit
  • There are no satisfactory alternative therapies available to the patient
  • The patient is not eligible for a clinical study
  • Adequate supply of therapy
  • Local and regional regulations

Please note: The fenfluramine US Expanded Access Program (US EAP) is available to full-time US Residents only. Participation in the US EAP is limited to patients currently residing in the US. Residency in the US must be for the duration of participation in the US EAP. Drug may not be shipped outside the US.

Requests for access to experimental therapies must be made by a qualified and licensed physician by emailing Zogenix’s Medical Information Department at medinfo@zogenix.com. Zogenix looks to acknowledge such requests within five business days after receipt of the email. More information on our clinical trials and our expanded access program can be found at clinicaltrials.gov.

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