Expanded Access Program

Purdue Pharma is committed to advancing the medical care of patients with quality pharmaceutical products. We are known for our pioneering research in pain, a principal cause of human suffering. Today, we work with new partners on innovative healthcare solutions in many therapeutic areas.

In order for new medicines to be legally approved for use in patients, pharmaceutical companies, including Purdue, are required to evaluate the safety and efficacy of the investigational medicine in clinical trials and submit this data to the Food and Drug Administration (FDA). For most patients, the only way to access investigational medicines is to participate in clinical trials. To learn more about available clinical trials visit clinicaltrials.gov and search by company, disease, or medicine.

In rare cases when patients do not qualify for clinical trials and have exhausted all available treatment options, regulators may grant permission for Purdue to provide a treating physician with an unapproved medicine. Such individual use of an unlicensed investigational medicine is often called “compassionate use” or “expanded access” but may go by other names.

For information from the FDA about expanded access in the U.S., click here.

Who is eligible for Purdue’s Expanded Access Program?

All of the following criteria must be met in order to be considered for expanded access to Purdue’s investigational medicines:

  1. The patient has a serious or immediately life-threatening disease or condition.
  2. There is no comparable or satisfactory alternative therapy for the disease or condition, or the patient has undergone appropriate standard treatment without success.
  3. The patient is ineligible for participation in any ongoing clinical study of the investigational medicine.
  4. There is sufficient evidence or understanding of a potential patient benefit from the use of the investigational medicine to justify its potential risks.
  5. The medicine must be part of an active and ongoing development process, and expanded access would not interfere within its development.
  6. There is an adequate supply of the medicine to perform necessary clinical studies as well as provide expanded access.

Patients interested in expanded access to Purdue’s investigational medicines should speak to their physician.

How do I request expanded access for an investigational medicine?

If a treating physician believes expanded access may be the only option for a patient, the physician should contact Purdue Medical Information at (888) 726-7535 press option 1 to make a formal request on behalf of the patient.  Requests will only be considered if submitted by the treating physician.  Alternatively, physicians may complete and submit the form below:

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By submitting this form, you are consenting to have the information that you provided to be collected and used by Purdue Pharma L.P. for processing your request for expanded access. Your information will be retained within a secure environment at Purdue.

Once this form has been submitted, it will be routed to the appropriate contact at Purdue, who will then communicate with the requesting physician within five business days. The requesting physician will then be directed to submit required documentation to Purdue.

How are submitted requests evaluated?

Each request will be evaluated by medical experts at Purdue who are knowledgeable about the investigational medicine.  We have a responsibility to the patient to weigh the potential benefit against the risks of the investigational medicine based on the information available at the time of the request.  Each request will be evaluated fairly and carefully by our medical experts.  The FDA must also approve the proposed use of the investigational medicine.  Every effort will be made to respond promptly once we have all the necessary information.