Orion Pharma Expanded Access Policy

We are committed to conducting clinical trials to evaluate the safety and efficacy of investigational therapies and to generate the evidence required for regulatory approval and broad patient access. Our R&D pipeline includes investigational medicines in clinical development across various therapy areas. We believe participation in well-designed clinical trials is the best way for patients to access investigational medicines before regulatory approval, while also contributing to the scientific evidence needed to evaluate potential benefits and risks. Expanded Access, sometimes called Compassionate Use, is one potential pathway for patients with serious or immediately life-threatening conditions to receive an investigational medicine outside of a clinical trial when no comparable or satisfactory alternative therapy is available. 
 
At this stage of our clinical development, Orion Pharma does not offer company-sponsored Expanded Access or Compassionate Use Programs for any of its investigational medicines.  For investigational medicines being developed in partnership with another company, Expanded Access is governed by the Expanded Access Policy of the partner responsible for the program. Our priority is to generate robust scientific and clinical evidence through ongoing studies to better understand the potential benefits and risks of these investigational medicines. We encourage all patients and healthcare professionals interested in Orion Pharma investigational medicines to visit the clinicaltrials.gov website to learn about Orion Pharma-sponsored clinical trials that may be actively recruiting patients.  
 
For questions regarding this policy, please contact headquarters@medinfo.orionpharma.com. 
 
Orion Pharma will periodically review the Expanded Access Policy and reserves the right to revise the policy at any time. Posting this policy does not guarantee access to any investigational medicine for any patient.