Compassionate Use, or Expanded Access

In cases where a clinical trial isn’t an option and the patient has exhausted all available treatment options, regulators may grant permission for us to provide a treating physician with an unapproved drug. Such individual use of an unlicensed investigational drug is often called “compassionate use” or “expanded access” but may go by other names.

It's important to remember that investigational drugs have not received regulatory approval; therefore, their potential risks and benefits are not yet established. Doctors and patients should consider all possible risks and benefits when seeking compassionate or expanded access to a product that is unapproved for the condition in which the patient and physician are seeking treatment.

While an expanded access program (EAP) is not opened for every investigational medicine or use, our company does not offer EAPs when investigational medicines are in early testing because there are still too many unknowns.

To be eligible for access to an investigational or unlicensed product, patients must meet the following criteria:

• Suffer from a serious or immediately life-threatening disease or condition
• Have undergone appropriate standard treatments without success, and comparable or satisfactory alternative treatments to diagnose, monitor or treat the disease or condition are not available
• Are ineligible for participation in any ongoing clinical study of the investigational drug, and
• Meet any other pertinent medical criteria for access to the investigational or unlicensed drug, as established by Endo

Please feel free to contact us with any questions
Phone: (800) 462-ENDO (3636)
Fax: (800) 329-ENDO (3636)
Email Us: /endopharma/contact-us