A year ago, at FDA’s request, NRx began a compassionate care (Expanded Access) program to make aviptadil more available to patients in need. We have reported our experience in nearly 350 patients, and numerous patients and families have shared their stories in various public forums. The compassionate care program was, of necessity, limited to a small number of hospitals because our investigational drug was being manufactured in minute quantities, barely sufficient for the needs of our multiple clinical trials. The rigors of an expanded access program were also incompatible with the administrative capabilities of many hospitals, particularly with staff stretched to the breaking point by the public health emergency.
As the pandemic has surged, our team at NRx has been receiving daily requests from doctors, patients, and families for emergency access to aviptadil (ZYESAMI™) as we await FDA’s action on our request for Emergency Use Authorization. We hear the daily heartbreak of fathers, mothers, siblings, and friends who have loved ones struggling to survive in the ICU, having exhausted all available remedies.
The emails are heart-wrenching requests for our investigational medicine, often made at a point where there is little hope of survival. Increasingly, those requests have been made under Federal and State Right to Try laws that allow an investigational medicine to be rushed to the bedside of patients with life-threatening diseases who have tried all approved alternatives.
With the start of commercial manufacture of aviptadil, we are finally in a position where we have an adequate supply of aviptadil for emergency use, sufficient to begin to respond to requests under the US Federal and State Right to Try laws. FDA’s guidelines related to those laws may be viewed on the Agency’s website. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
Right to Try laws are meant to offer patients diagnosed with life-threatening diseases or conditions an investigational medicine under the following conditions:
- The patient has tried all approved treatment options
- The patient is unable to participate in a clinical trial
- The patient’s physician believes the investigational medicine is appropriate
- NRx doctors and medical experts agree that our investigational medicine may have a reasonable likelihood of producing benefit to the patient
We are continuing multiple phase 3 trials of aviptadil, both sponsored by our company and by the US National Institutes of Health. In the meantime, we have established a streamlined program for requesting aviptadil under Right to Try, which may be accessed on our website. LINK
NRx stands ready to help and do its part to help our world find its way out of a crisis that is killing thousands of Americans each day and tens of thousands around the world.
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