EpiPen alternative: FDA may approve first nasal spray for anaphylaxis


A father gives his son a nasal spray.Share on Pinterest
In the case of a severe allergic reaction, study results showed that nasally administered epinephrine had an influence on heart rate and blood pressure similar to that of an injection. Maskot/Getty Images
  • Anaphylaxis, a severe allergic reaction, is often treated with epinephrine.
  • Epinephrine is given by injection through devices such as EpiPens.
  • But people may soon have the ability to use a nasal spray.
  • Studies indicate that the nasal spray may be as effective in treating anaphylaxis as an injection.

Anaphylaxis, a potentially life-threatening allergic reaction, is common in the United States. It is estimated that up to 5% of people have experienced anaphylaxis.


It’s vital to treat severe allergic reactions as quickly as possible, and current treatment involves using a needle-based device such as an EpiPen to get an injection of adrenaline.

However, a potential new nasal spray device, known as the Neffy, could soon be used to deliver epinephrine.

An external advisory panel of the Food and Drug Administration (FDA) recently voted in favor of the product.

In a statement, ARS Pharmaceuticals, the makers of Neffy, said a final decision from the FDA is expected by mid-2023.


Study data provided by ARS Pharmaceuticals showed that nasally administered epinephrine has a similar influence on heart rate and blood pressure compared to an injection.

This is critical, because during anaphylaxis, heart rate slows and blood pressure drops, making it difficult for blood to move throughout the body to major organs, explained Dr. Manan Shah, co-founder and medical director of Wyndly .


The nasal device proposed for use in the administration of epinephrine is not new to the medical field.

The Unit Dose Sprayer device used to administer Neffy is the same technology used for drugs such as Narcan (naloxone), Dr. It is also known as adrenaline.

In addition to addressing reactions in vital organs such as the heart and lungs, epinephrine also prevents the release of histamine and other chemicals responsible for spiraling an allergic reaction, said Dr. Shuba Iyengar, MPH, co-founder and chief medical officer of Allermi.

It’s an invaluable medical treatment for people who have a history of anaphylaxis, she shared with Healthline.

The nasal spray delivers a fine mist of epinephrine solution into the nasal cavity, Iyengar explained. The drug [is then] rapidly absorbed through the moist lining of the nasal passages which is lined with blood vessels.

From there, epinephrine enters the bloodstream, where it binds to specific cell receptors to improve blood flow and reverse the symptoms of a severe allergic reaction, she said.

The good news is that epinephrine works quickly. OShea said symptoms start to ease within 5 to 10 minutes after injecting into the muscle.

Approximately 20% of patients require a second dose of adrenaline and administration may be repeated at 5-15 minute intervals if there is no response or inadequate response, or even sooner if symptoms are acutely significantly worsening, has said OShea.

If you have an allergic reaction that requires adrenaline, you should still go to the hospital for follow-up care even if the initial symptoms of anaphylaxis have subsided.

The FDA committee reviewed various data relating to the effectiveness of the Neffy device and any potential drawbacks.

Several studies involving over 600 individuals were conducted by ARS Pharmaceuticals to compare the effects of epinephrine when administered via the Neffy and EpiPen.

In blood measurements taken 10-20 minutes after administration, the levels of adrenaline in the body were similar between the two devices. The effects on anaphylactic symptoms were also comparable.

When a second dose of epinephrine was given 10 minutes after the first, the effects of the Neffy and EpiPen on anaphylaxis were again similar. Some results also showed that the nasal device had a significantly greater influence on blood pressure.

Additionally, none of the studies reported serious adverse effects following use of the nasal device.

It was noted, however, that epinephrine levels in the body decreased more rapidly when delivered by nasal spray rather than injection, and the committee acknowledged that durability could be a future talking point.

There was also some concern about the impact of nasal congestion on epinephrine intake.

While the nasal spray did affect anaphylactic symptoms in those with a runny or stuffy nose, ARS Pharmaceuticals admitted that a second dose would likely be needed under these circumstances.

Ultimately, the committee voted in favor of the nasal device, with 16:6 in support of its use by adults and 17:5 in favor of its use by children (over 30kg).

While the FDA does not have to follow the recommendations or guidance of its committees, it used to do so declared may this expert advice help them make sound decisions based on available science.

Many people are concerned about giving an injection possibly because of pain or fear of administering incorrectly, shared Dr. Tiffany Owens, an allergist/immunologist at Ohio State University Wexner Medical Center.

However, the nasal spray device will be a needle-free system and will be smaller than auto-injector devices, he told Healthline.

This could result in more patients carrying their epinephrine devices with them, Owens shared, and will hopefully reduce hesitancy to administer epinephrine.

Previous research shows that 52% of people who qualify for an EpiPen don’t use it.

While the nasal spray device offers a promising alternative, Van Acker said it doesn’t eliminate the risk of misuse or misuse.

Patients should be provided with proper training and counseling about whatever epinephrine rescue medications they have on hand, he said.

This summer, FDA experts will revision the clinical data provided and determine whether or not to approve the product for public use.

Van Acker believed the prospects were promising. Based on what we know about epinephrine and the data submitted to the FDA, I believe Neffy may be approved for use/sale.

He continued: Neffy’s rapid onset of action, side effect profile, and analysis of BMI and drug exposure are compelling data to support its approval.

Essentially, it’s up to the FDA to determine if more data is needed. Before release for public use, its safety and efficacy must be well established.

I think [the data] it’s promising, but it hasn’t yet given us enough information to draw any concrete conclusions, Shah concluded.

First of all, anaphylaxis should be promptly treated with epinephrine, said Dr. Kelly O’Shea, assistant professor in the Department of Internal Medicine at the University of Michigan Mary H. Weiser Food Allergy Center.

While epinephrine is highly effective in treating severe allergic reactions, what is it and how does it work?

Epinephrine is a hormone and a neurotransmitter, explained St. Van Acker. It is also known as adrenaline.

[It] works by stimulating alpha-, beta1– and beta2-adrenergic receptors, which are found throughout the body, he told Healthline.

Stimulation of these receptors helps counteract the symptoms of anaphylaxis.

Anaphylaxis is the most serious type of allergic reaction

[It] it typically occurs within seconds to minutes of exposure to an allergen, said Dr. Ruchi Gupta, MPH, professor of pediatrics and medicine at Northwestern University Feinberg School of Medicine and attending clinician at Ann & Robert H. Lurie Childrens Hospital in Chicago.

The signs may be mild at first before quickly developing into more severe symptoms.

The reaction typically includes more than one body system, Gupta told Healthline. Therefore, a number of symptoms can occur, ranging from itching and redness of the skin to swelling of the throat, lips and tongue, stomach pain, nausea and diarrhea.

While nut allergies are commonly associated with anaphylaxis, that’s not the only potential cause.

You can develop a food allergy to virtually any food, Gupta said. The most common in the United States include peanuts, milk, shellfish, tree nuts, eggs, finfish, wheat, soy and sesame.

Allergic reactions can also occur after taking medications, such as certain antibiotics and nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin.

Additionally, insect stings can also lead to severe reactions, particularly stings from wasps and bees, Gupta shared.

If you think you are having an anaphylactic reaction, call 911 immediately and, if available, use an epinephrine auto-injector (such as an EpiPen).

The person suffering from anaphylaxis should lie on their back, Van Acker said, and if they are vomiting, they should be turned onto their side to avoid choking.

Even if you feel better, you should still go to the emergency room to be properly checked and monitored.

It’s also important to watch for recurring symptoms for a few days afterward, Gupta shared.

Symptoms can recur 1 to 72 hours (most within 8 hours) after the initial stage’s apparent resolution, he revealed.

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