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