Compassionate use requests for investigational products

Travere Therapeutics is committed to developing investigational products for people living with rare disease

We believe that participating in a clinical trial is the best way for patients to access our investigational products, however, we recognize that there are situations in which patients may not be able to access our investigational products through our clinical trials.

For example, some individuals may not satisfy all the eligibility conditions required to enter our clinical trial, some may have a critical need for immediate care, and some may live in a location that is not accessible a participating clinical trial site. For patients in any of these situations, we will consider requests for special access to our investigational products, which is often referred to as compassionate use or expanded access.

Each request will be carefully considered for many factors, including the circumstances and medical history of the patient, the local and national laws and regulations, the potential risks for each patient, and the best interests of the entire patient community. It is important to remember that the regulatory agencies (such as the US Food and Drug Administration (FDA) or European Medicines Agency) have discretion to grant or deny access to investigational medications through the compassionate use program. Learn more about the FDA’s expanded access policies and requirements and the European Medicines Agency policy.

If you feel you may be eligible for compassionate use of one of our investigational products, your physician must submit a request on your behalf. Treating physicians who would like to request access to one of our investigational products are encouraged to contact us at compassionateuse@travere.com or 877-659-5518. Travere Therapeutics aims to acknowledge receipt of requests to the requesting physician within seven business days.

Submissions will be reviewed by an internal committee who will carefully consider each request based in part on the following:

  • Is the patient ineligible to participate in a clinical trial?
  • Is there is sufficient evidence to expect that the investigational product will have an acceptable safety profile for the intended patient?
  • Is there enough of the investigational product to support the compassionate use request without jeopardizing other needs, such as ongoing clinical trials?
  • Does the patient have a serious or imminently life-threatening disease or condition?
  • Are there other comparable or suitable alternative treatments available?
  • Can the requesting physician meet the criteria for administration of the investigational product?

It’s also important to know that the compassionate use of an investigational product may be discontinued at any time at the discretion of the treating physician, the patient or their caregiver, the local regulatory agency, such as the FDA, or Travere Therapeutics.

To learn more about our compassionate use/expanded access program and process, please contact compassionateuse@travere.com or 877-659-5518.

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