Expanded Access (“Compassionate Use”) Policy

Ouro Medicines (Ouro) is committed to developing safe and effective therapies for the treatment of autoimmune diseases. Participation in clinical trials is the best way to access our investigational medical products, and patients are encouraged to speak to their doctors about whether a clinical trial is right for them. Treating physicians can find more information on our ongoing clinical trials by visiting clinicaltrials.gov or by contacting Ouro at clinical@ouromeds.com. Ouro will acknowledge inquiries as soon as possible, usually within 5 business days of receipt.

Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of a clinical trial. Guidelines for considering Expanded Access have been provided by the US Food and Drug Administration (FDA). Based on these guidelines, Ouro may consider requests for Expanded Access in rare circumstances when an individual cannot participate in a clinical trial and no comparable or satisfactory alternative therapy options are available. Treating physicians who are considering Expanded Access may contact Ouro at clinical@ouromeds.com. Ouro will acknowledge inquiries as soon as possible, usually within 5 business days of receipt.

Pursuant to the 21st Century Cures Act, Ouro may revise this policy at any time and this policy does not serve as a guarantee of access to any specific investigational therapy for any individual.

Link to FDA’s Expanded Access information for patients:
https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients

Link to FDA’s Expanded Access information for physicans: 
https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians