Could a nasal spray replace an EpiPen? Here’s what an allergist says

For the thousands and thousands of Americans who’ve a meals allergy, medical doctors advocate they at all times carry an epinephrine auto-injector, similar to an EpiPen, in case they’ve a extreme allergic response. But a just lately accepted nasal spray could provide a needle-free different within the close to future.

This August, the U.S. Food and Drug Administration accepted Neffy, which is the primary epinephrine product for the remedy of anaphylaxis that isn’t administered by injecting a needle.

Anaphylaxis is a extreme and probably life-threatening allergic response that may occur seconds or minutes after an individual is uncovered to one thing they’re allergic to, similar to sure meals, drugs, or insect stings. Epinephrine is a drugs used to deal with anaphylaxis, and it historically is run with an auto-injector—a needle—within the thigh.

Neffy is predicted to be accessible within the U.S. by early October. Although it’s not but accessible to prescribe to sufferers in Colorado, Suzanne Ngo, MD, an allergist and immunologist at Children’s Hospital Colorado and the UCHealth Allergy and Immunology Clinic, is brainstorming methods to speak in regards to the new product along with her sufferers.

“It’s very encouraging that there’s this extra possibility as a result of there was a barrier of this medication being administered with a shot. I feel that may scare individuals from utilizing it,” says Ngo, an assistant professor within the Division of Allergy and Clinical Immunology on the University of Colorado Department of Medicine. “If now we have different choices which can be simply as efficient, perhaps there will likely be much less hesitation to make use of it.”

However, Ngo cautions that the efficacy of the gadget remains to be not totally identified.

“We want time to know if it really is equal to the EpiPen as a result of, as of proper now, many of the research have been totally on wholesome individuals,” she says. “There’s been extra restricted knowledge on truly utilizing it within the setting of an allergic or an anaphylactic response, so I feel that is the place with the ability to acquire extra of that knowledge will give us extra confidence with utilizing it.”

How it really works

Neffy can be utilized on each adults and kids who weigh greater than 66 kilos. It is a single-dose nasal spray that’s administered into one nostril.

“It primarily has epinephrine in it, which then is absorbed into the nasal mucosa and exerts its results. There are different drugs which have utilized the identical type of nasal supply strategy, similar to Narcan, which is utilized in emergency conditions for opioid overdoses,” Ngo says.

On its web site, Neffy recommends carrying two Neffy gadgets always. A second dose could be given if there isn’t a enchancment in signs or if signs worsen. This second dose includes utilizing a brand new nasal spray to manage Neffy in the identical nostril.

Neffy advises customers to not sniff throughout or after use. It additionally recommends that if an individual is utilizing their proper hand to manage the medication, the spray ought to go in the suitable nostril; equally, left-handed dosing ought to be to the left nostril.

“The hope is that those that are extra hesitant to make use of a needle could also be extra keen to make use of this to deal with a extreme allergic response,” Ngo says. “It’s additionally a barely smaller gadget that could be simpler to hold than an auto-injector.”

Potential considerations

Given that it’s a nasal spray, there have been some considerations about whether or not Neffy can get the medication into an individual’s system as successfully as an auto-injector can.

“One potential concern was that a number of our sufferers have nasal allergic reactions and at all times have a runny nostril. And you probably have a baby who’s having an allergic response and crying and snotty, can we get sufficient treatment of their system?” Ngo says.

“But they’ve finished research the place they examined sufferers who’ve nasal allergic reactions, the place they primarily uncovered them to issues they’re allergic to with a purpose to set off these nasal signs after which used Neffy.

“Those preliminary research indicated that it did not have an effect on the absorption of the treatment. If that’s constant when treating allergic reactions, I feel that is reassuring as a result of that is one of many considerations many individuals may have,” she provides.

Another concern Ngo has about Neffy is the flexibility to shortly administer the medication to a baby who will not be cooperating.

“It’s a bit simpler to carry a baby’s leg nonetheless and do an injection versus administering the nasal spray for a kid who could also be shifting their head round,” she says. “The fear is, for those who aren’t capable of spray it the place it must go, it’s possible you’ll be dropping that treatment and never treating the kid.”

Cost can be a possible concern, Ngo says, as a result of it’s unknown how completely different insurance coverage insurance policies could cowl Neffy.

“That’s at all times one thing now we have to think about, as a result of there are completely different epinephrine gadgets on the market and we generally have to select whichever product the affected person’s insurance coverage will cowl. That could differ from affected person to affected person,” she says.

The want for extra knowledge

Ngo needs sufferers to understand that many of the research on Neffy have primarily been on wholesome individuals who weren’t experiencing anaphylaxis—a limitation of the medical trials attributable to moral pointers.

“Because that is probably a life-threatening response that we’re treating, the ethics of inducing anaphylaxis to somebody simply to check Neffy’s efficacy will not be possible,” she says. “However, now we have different alternatives when sufferers usually tend to have anaphylaxis, similar to a meals problem process, the place we are able to examine effectiveness for Neffy to deal with anaphylaxis.”

As Neffy turns into extra accessible and is used to deal with individuals experiencing anaphylaxis in real-life situations, it is going to be vital to gather knowledge on the efficacy of the gadget. This knowledge can then assist allergists like Ngo determine whether or not they wish to advise their sufferers to make use of the product or not.

“I feel we’re all cautiously making ready for the way we’re going to advocate this to sufferers till we collect a bit extra knowledge to reassure us that that is going to be simply as efficient in treating these reactions as an auto-injector is,” she says.