Pre-Approval Access to Investigational Medicines Policy
At NRx Pharmaceuticals, we are committed to including patients in need of potentially lifesaving cures in our clinical development programs at the earliest opportunity. During the initial stages of development, this may take the form of “named patient” Investigational New Drug licensing that must be approved by the US Food and Drug Administration (FDA) on an individual basis. As development continues, we may initiate Expanded Access programs (previously known as compassionate care) with the encouragement of the FDA. The Aviptadil Expanded Access Program is now only limited to existing sites.
IV Aviptadil under Right to Try
Once a drug is in phase 3, we may also make that medicine available under Federal and State Right to Try laws, upon request of patients, families, and the treating physicians, provided our medical consultants concur that our investigational products have a reasonable likelihood of an acceptable risk-benefit for the patient.
At this time, NRx Pharmaceuticals is able to provide limited access, on a case-by-case basis, to its investigational medicine Aviptadil through the Aviptadil Right to Try Program. Patients considered for this program would need to meet the following minimum requirements for access:
- Patients who have a serious disease or condition and whose life is immediately threatened by this disease or condition. Critical COVID-19 meets this standard.
- Patients who have no comparable or satisfactory therapy to treat their disease or condition.
- Patients who are unable or ineligible to participate in a clinical trial involving Aviptadil
For more information, please contact us at ZyesamiRTT@nrxpharma.com.
The Aviptadil Right to Try Program is subject to drug availability and medical review by NRx Pharmaceuticals. NRx Pharmaceuticals has selected Clinigen to administer the Aviptadil Right to Try Program.
In the event you experience technical difficulties with the application form or need to connect with our partners at Clinigen on behalf of your patient, please use the following contact information: