Update by CB: A PR person emailed us and wanted us to add: “neffy received FDA approval on Aug. 9 and is expected to be available in the US market in roughly eight weeks.”
I’ve briefly alluded to this before, but I do not like needles. I am pro-science and pro-vaxx; I just don’t enjoy the process. And by “don’t enjoy,” I mean I devolve to a sniveling level of cartoonish histrionics that has only somewhat improved in adulthood. You’re stabbing me with a pointy thing — of course my knee-jerk reaction is going to be to prevent it at all costs! So I’ve always considered myself lucky that (as yet) I don’t have any allergies severe enough that require the need of an EpiPen. Well, there’s good breaking news for us trypanophobes: the FDA has just approved a nasal spray for treating anaphylaxis.
The first-ever needle-free alternative to the EpiPen and similar epinephrine autoinjectors has been approved by the Food and Drug Administration to treat anaphylaxis.
Neffy, a nasal spray that delivers a dose of epinephrine, is the first of its kind that isn’t delivered by injection. Until Neffy’s approval, the only way to stop the life-threatening response to an allergic reaction was with an injectable like the EpiPen, which comes pre-filled with a dose of the medication.
“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, Neffy provides an important treatment option and addresses an unmet need.”
As the Mayo Clinic explains, “Anaphylaxis is a severe, life-threatening allergic reaction. It can happen seconds or minutes after you’ve been exposed to something you’re allergic to. Peanuts or bee stings are examples.”
Anaphylaxis “occurs in about one in 50 Americans,” the Asthma and Allergy Foundation of America states, adding, “Many believe the rate is higher than that. It is probably closer to one in 20.”
The Mayo Clinic says symptoms include skin reactions (like hives), low blood pressure, nausea, fainting — and “constriction of the airways and a swollen tongue or throat, which can cause wheezing and trouble breathing.”
Food allergies are on the rise, according to Food Allergy Research and Education, with 33 million Americans citing at least one food allergy.
“Milk, egg, peanut, tree nuts, wheat, soy, fish and crustacean shellfish were identified as responsible for at least 90 percent of the serious food allergy reactions in the U.S.,” the organization says.
Peanut allergies, specifically, are rising — and as the Mayo Clinic points out, “Peanut allergy is the most common cause of food-induced anaphylaxis.”
“Even tiny amounts of peanuts can cause a serious reaction that can even be life-threatening.”
In January, a 25-year-old with a nut allergy died of anaphylactic shock after eating cookies that didn’t list peanuts on the label, and last year, a man from Texas died after eating a taco that didn’t list peanut butter as an ingredient.Although no details have been released about when Neffy will be available, the FDA has granted the product Fast Track status, which expedites its release to the public.
This is such great news! I’m so relieved for all the little kids afraid of needles (who sometimes grow up to be big adults afraid of needles; hi, that’s me!) that they’ll have this equally effective, much gentler option to the EpiPen. This is such a boon for anyone who gets queasy about shots, as the article points out. Surely this new epinephrine spray will help save lives. While People reports that there’s no word on when it will be available, the Allergy and Asthma Foundation estimates that it will be released around October of this year. And not for nothing, but “Neffy” already sounds like the name of one of the stuffed animals lining a toddler’s bed, which will make it even more friendly for the kids who’ll need it. In fact, wouldn’t it be great if they drew up an animated Neffy mascot character to help make the spray approachable to kids?
If Neffy (this is a “fluffy” name!) is just as effective as the epi pen, this is an excellent break through. Although, tbf, I’ve experienced a child having a life-threatening reaction a few times, and, trust me, the epi pen wasn’t what scared them.
They’re developing so many drugs to be used via nasal sprays now besides epinephrine, like flu “shots”, and the Corona vaccine, among other things, so this is quite a good time to be alive!
Keeping my fingers crossed for you, Kismet, to stay well until theses drugs are available — even if you luckily don’t have severe allergies.
As someone with a severe peanut allergy this sounds like great news! That feeling of not being about to breathe and your chest feel like it’s turned to concrete then getting that shot from an Epipen is not something I ever want to go through again as it feels like your heart is going to explode through your chest. I hope this will be an easier way of delivering the necessary adrenalin?
❤️
A nasal spray will also lower the threshold for bystanders to apply ephinephrine if the allergic is not able to to it themself. An Epi-Pen is simple to use but inserting a needle into another person still feels far more difficult than applying a nasal spray.
This!! My nephew has anaphylactic allergies and has had an Epi-Pen since he was a toddler. When he was little, the thing that terrified my mother the most about taking care of him was the possibility of having to administer his Epi-Pen, no matter how many times my brother showed her how to do it. She had no problem with normal little kid death-defying behavior – she had raised three of us and taught in an elementary school for 25 years, but the idea of having to give her grandson an injection absolutely terrified her.
She’d given me eye drops for 10 years when I was a child. A nasal spray would have been so much easier for her.
As a person with an anaphylactic sting allergy, I’m thrilled about this! Epi autoinjectors take up a lot of room in a handbag, and are failry heavy when you band them together, because you have to carry two all the time.
Totally agree, Epipens are awkward to carry around and I’m looking forward to something smaller and more manageable. And it looks like it will be $199 through GoodRx and BlinkRx, so more affordable, too.
Thank you Kismet for writing about this news, I hadn’t seen it yet!
Yes! I am thrilled! And two epipens are so danged expensive! I had to carry them for work (in the field) and always forgot them in my field vest in my truck, which meant in the Georgia summer the interior of my truck went WAY above the recommended storage temperature. I notice this nasal spray can tolerate higher temps. Good! Cheaper, lighter, easier to carry & use, I’m in!