The food allergy community received some bad news last week when — despite all indications to the contrary — the FDA denied approval of neffy™, the first needle-free emergency epinephrine candidate to be considered by the agency despite their expert review panel voting 17-5 for approval of the device for children and 16-6 for adults.
We MUST take action now to ensure the FDA understands that fear of the needle is a major reason for hesitation in administering epinephrine in an anaphylactic emergency, leading to poorer outcomes and unnecessary tragedy.
SnackSafely.com has initiated a petition on Change.org urging the FDA to approve nasal epinephrine. Here is what it says:
As a food allergy advocate and concerned parent of a child with severe food allergies, I am writing this petition to urge the Food and Drug Administration (FDA) to approve nasal epinephrine as an alternative delivery mode for emergency anaphylaxis treatment.
Anaphylaxis is a life-threatening reaction to a food, drug, insect venom, or environmental substance. Epinephrine is the only treatment that can halt and reverse the progression of anaphylaxis, but it must be administered promptly following onset to have effect.
The majority of anaphylactic deaths are due to delays in administering the drug, and one primary reason for that delay is fear of the needle that current emergency epinephrine devices employ.
Today’s standard — the epinephrine auto-injector — requires the patient or caregiver to stab the patient in the outer thigh, a daunting prospect, especially for children. I have heard stories of children hiding their reactions for fear of the subsequent jab, which has the potential to result in tragedy.
Even as a food allergy advocate, I am embarrassed to say that we have delayed administering epinephrine, viewing the needle as a high bar to clear despite knowing the potential consequences.
Nasal delivery of epinephrine eliminates this fear and would result in more prompt administration of the drug when anaphylaxis is first suspected. Furthermore, clinical studies have shown that nasal administration of epinephrine delivers the drug as effectively as auto-injectors and intramuscular injections.
The FDA’s own advisory panel voted 17-5 to approve a nasal epinephrine candidate for children and 16-6 for adults in May of 2023, but the agency changed direction and denied approval of the device in September. We, the allergic community, desperately need this mode of delivery, which will eliminate hesitation, lead to better outcomes, and save lives.
I urge the FDA to consider the importance of this issue and take swift action. The agency must ensure that fear of the needle and the hesitation it causes do not put more lives in jeopardy.
Thank you for your attention to this matter.
There are two ways to get involved and advocate for this important tool in the fight against anaphylaxis:
- Sign the petition and add your personal comment as to why approval of nasal epinephrine is important to you;
- Send your senators and your representative a copy of the petition and urge them to act on your behalf. You can look up contact information for your senators here and your representative here.
It’s important to do both because we need the FDA to understand the importance of approval and our legislators to pressure the FDA to act on our behalf.
Please take a few minutes to engage and be sure to share with family, friends, coworkers, and on social media and in discussion groups you participate in. With your help, we can accelerate approval, expand our limited options for emergency epinephrine, and drive down prices.