FDA has approved an expanded access protocol for the use of RLF-100 in patients with Critical COVID-19 and Respiratory Failure. RLF-100 remains an investigational drug in clinical trials. The purpose of this expanded access program is to serve patients with a life-threatening need who don’t qualify for or cannot access the FDA phase 2/3 clinical trials currently underway.
Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Expanded access may be appropriate when all the following apply:
- A Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
What is Expanded Access?
Expanded Access was designed by FDA and the US Congress to address public requests for access to potentially lifesaving drugs ahead of FDA approval. The Reagan Udall Foundation was chartered by Congress to help patients and doctors understand the complexities of expanded access.
How do I learn about the RLF-100 Expanded Access Program?
The Federal Government maintains www.clinicaltrials.gov to inform the public about all clinical trials and expanded access programs approved by the US FDA. You can read more about the RLF-100 expanded access program.
What are the risks of participating in an expanded access program?
Physicians and patients should understand that drugs delivered under an expanded access program do not yet have a determination of safety and efficacy by the FDA. For further information, click here.
Who assures patients understand the risks associated with expanded access?
The use of any investigational drug, whether in a clinical trial or an expanded access program requires the informed consent of the patient, or their legally authorized representative. This consent form must be approved by an Institutional Review Board, in this case, Advarra.
Does my doctor/hospital get paid for my participation in expanded access and will I have to pay?
Unlike a clinical trial, NeuroRx (the sponsor) does not provide compensation to physicians and hospitals for the expanded access use of RLF-100. Under the law, NeuroRx is allowed to charge for the costs of delivering its drug under expanded access. For further information, click here.
Is anybody watching out for my safety?
Doctors and hospitals are required to report side effects of all drugs. In the case of an expanded access drug, in addition to the pharmacovigilance requirements of the drug company, an independent Data Monitoring Committee is established to review all Serious Adverse Events and advise NeuroRx whether to continue the program. For further information, click here.
Only you can make that decision with the expert advice of your doctors and counsellors. The RLF-100 expanded access program is designed to provide a potentially lifesaving option for patients who have no other, already-approved alternatives in the setting of COVID-19 Respiratory Failure. Your doctor is welcome to reach our to our board-certified medical experts to determine whether expanded access to RLF-100 might be right for you. firstname.lastname@example.org
You may read first-hand accounts from patients who have taken RLF-100: