Epinephrine Nasal Spray to Treat Anaphylaxis is Now Available
November 08, 2024
The epinephrine nasal spray neffy® is now available for people at risk of anaphylaxis, a severe allergic reaction. It is available by prescription only. The manufacturer is ARS Pharmaceuticals.
The approval of neffy by the U.S. Food and Drug Administration (FDA) last August was a major milestone for people with severe allergies. It offers a new way to treat anaphylaxis.
The medication neffy becomes the first epinephrine nasal spray approved in the United States. It joins epinephrine auto-injectors as treatments for a severe allergic reaction, or anaphylaxis. Epinephrine auto-injectors received FDA approval in 1987 and have been the standard treatment for anaphylaxis ever since.
The new nasal spray is a needle-free alternative to the auto-injector devices. It is a 2 mg spray approved for adult and pediatric patients weighing at least 66 pounds.
A neffy prescription consists of two single-dose nasal spray devices. Each device is a single dose administered into one nostril. As with epinephrine auto-injector products, a second dose (using a new nasal spray in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen. Some patients may need to seek emergency treatment after using neffy in case further treatment is needed.
Epinephrine is the first-line treatment for anaphylaxis. No other medication stops the life-threatening effects of anaphylaxis.
What are the benefits of a needle-free epinephrine nasal spray?
Epinephrine nasal sprays are expected to be easier to carry and use than auto-injectors. Many people with anaphylaxis and caregivers tend to hesitate when using auto-injectors, in part because of worries about injecting a needle. Studies show any hesitation or delay in administering epinephrine puts patients at risk for worse outcomes, and even death.
“We are very pleased the FDA approved neffy as a safe, efficient and effective treatment option for people at risk for severe allergic reactions,” Allergy & Asthma Network CEO Lynda Mitchell says. “As a needle-free treatment option, we expect that neffy will reduce delays in treating anaphylaxis due to fear of needles. The epinephrine nasal spray gives people more choice to use the epinephrine treatment they want, when they need it.”
It became clear in recent years that patients and families preferred an epinephrine delivery device that did not involve needles.
In 2018, Allergy & Asthma Network recruited patients and caregivers for a study that examined preferences for nasal spray epinephrine. Researchers surveyed 372 patients and caregivers overall.
Their findings:
- 91% of study participants would consider using an epinephrine nasal spray instead of an auto-injector;
- nearly 72% would prefer using an epinephrine nasal spray instead of an auto-injector;
- 82% would prefer needle-free epinephrine instead of an injection;
- 80% would be more likely to carry a smaller and easier to conceal epinephrine product;
- 43% disliked the idea of injecting a needle to administer epinephrine.
Is neffy safe and effective?
FDA says it approved neffy based on four studies in 175 healthy adults. The studies measured the amount of epinephrine in the blood after the adults were given either neffy or an epinephrine auto-injector.
Study results showed similar epinephrine levels between neffy and the auto-injector. The nasal spray demonstrated similar increases in blood pressure and heart rate as auto-injectors, two key effects of epinephrine in the treatment of anaphylaxis.
A separate study of neffy in children weighing more than 66 pounds showed the amount of epinephrine in the blood was similar to adults who received neffy.
Side effects after taking neffy were generally mild in the clinical trials. No serious adverse events were reported.
In April 2024, ARS Pharmaceuticals announced it completed a clinical study for neffy. The ARS clinical trial compared two neffy doses and two doses of an epinephrine auto-injector under normal conditions and after a nasal allergen challenge. ARS says the study results show the safety and effectiveness of the epinephrine nasal spray is greater than or similar to the auto-injector. Repeat dosing in the same nostril was greater in exposure than dosing once in each nostril and greater than an injection.
ARS also informed FDA it completed testing for nitrosamines, a chemical contaminant. The testing found no measurable levels of nitrosamines. The research was announced in February 2024 at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Washington, DC.
What are the side effects with neffy?
As with any medication, neffy does come with potential side effects. The side effects are the same as other medications with epinephrine. These may include:
- throat irritation
- headache
- nasal discomfort
- a tingling or itchy nose
- nasal congestion
- runny nose
- feeling jittery
- fast heartbeat
Some people may also experience fatigue, abdominal pain, mouth numbness, dizziness, nausea and vomiting.
These side effects are usually short-lived. They typically subside within 30 minutes. The benefit of taking a potentially life-saving medication far outweighs the risk of these temporary side effects.
Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy.
Can people with nasal conditions use neffy?
FDA approved neffy with a warning that having nasal polyps or a history of nasal surgery may affect the absorption of epinephrine. People with these conditions should talk with their healthcare provider about using an epinephrine auto-injector.
ARS clinical studies also examined neffy in people with allergic rhinitis symptoms such as nasal congestion or runny nose. The results showed similar levels of epinephrine in people without nasal congestion or runny nose.
How much does neffy cost?
One of the main concerns for people is the cost of life-saving medications. ARS Pharmaceuticals is offering patient support so that neffy is accessible and affordable to everyone.
People who have private health insurance that covers neffy can pay $25 for each prescription. This is through a co-pay savings program.
For people without insurance or who have a health plan that does not cover neffy, or if a patient faces high out-of-pocket costs due to a high-deductible plan, ARS is offering neffy for $199 via BlinkRX, a digital pharmacy. This cash price is also available for people who use GoodRx.
In addition, the ARS Pharma Patient Assistance Program (PAP) will provide neffy at no cost to eligible U.S. residents who are uninsured or underinsured, meet certain eligibility criteria, and have exhausted all other options.
Are there more epinephrine treatments on the horizon?
In addition to neffy, more epinephrine treatments are in development.
Bryn Pharma is developing an epinephrine nasal spray currently referred to as NDS1C. The company reported positive results in clinical trials for NDS1C at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in Washington, DC in February 2024.
Bryn Pharma’s studies suggest NDS1C is as effective as an auto-injector. The studies found the epinephrine nasal spray reached similar levels of epinephrine absorption in the body as the auto-injector. Researchers reported the nasal spray was safe and well tolerated, and side effects were mild.
In addition to an epinephrine nasal spray, an under-the-tongue (sublingual) strip containing epinephrine is in clinical trials. The strip, called Anaphylm™, is manufactured by Aquestive Therapeutics. Aquestive recently announced positive results from clinical trials showing Anaphylm provides rapid and sustained levels of epinephrine similar to auto-injectors.
The strip is similar in size to a postage stamp. It dissolves under the tongue on contact. It can be carried safely in your pocket.
Questions and answers on neffy and what it means for severe allergy treatment
We spoke with board-certified allergist and immunologist Purvi Parikh, MD, Allergy & Asthma Network national spokesperson, about the neffy approval. She answered some common questions about this new treatment option.
Q: How does neffy work?
A: It works by delivering epinephrine into your body through a nasal spray. The medication is the same found in auto-injectors, except the nasal spray is administered directly into the nostril instead of by needle. The medication will stop or slow down a severe or life-threatening allergic reaction.
Many people with food or insect venom allergies always carry epinephrine. For decades, this meant carrying an epinephrine auto-injector with a needle. The nasal spray now offers a needle-free alternative.
The medication neffy is for use in the nose only. Do not spray it in your eyes or mouth.
Q: How quickly does neffy work?
A. It usually takes effect within five minutes. The rapid treatment of neffy is vital in stopping a severe allergic reaction. It can also prevent the progression of life-threatening anaphylaxis.
Q: How do you take neffy?
A: Insert the nozzle of the nasal spray fully into one nostril. Hold the nasal spray straight into the nose. Do not angle it against the inside or outside wall, as you could lose some of the medication. Press the plunger firmly to activate the device and deliver the epinephrine.
Avoid sniffing during and after taking the medicine.
The medication is given as a single dose. It’s important to always carry two neffy devices, just like you would with auto-injectors. You may need a second dose of neffy if your symptoms continue or come back.
If a second dose is needed, use a new neffy nasal spray. Insert it into the same nostril you used for the first dose. Do not reuse the neffy you used for the first dose. The second dose should be taken at least five minutes after the first dose.
People who take neffy should seek additional emergency medical treatment if they continue to have severe symptoms or their symptoms worsen.
Q: How will neffy impact the allergy community?
A: The medication neffy will certainly change how severe allergic reactions are treated for those who choose this option. Many people – particularly children – are afraid of needles. They may be scared to inject themselves or others. They may feel apprehensive on their ability to successfully use an auto-injector. Caregivers and bystanders may feel more comfortable administering a nasal spray in an emergency.
This ease of use of neffy means more people will get the emergency medication they need to treat a severe allergic reaction.
Many schools and other public places or services may adjust their stock epinephrine policies as well. They may choose to stock the epinephrine nasal spray instead of the needle-based auto-injector due to ease of use. It may become more widely available in public places.
Q: What other benefits does neffy provide?
A: The nasal spray’s compact size makes it easy to carry. You can store it in a pocket, purse, or bag, ensuring that it is always available for quick use.
The neffy device itself is easy to use. It does not require extra training. It is smaller than auto-injectors. And it is easier to carry and dispose of after use. These features make it an attractive option for both patients and caregivers.
Q: Does neffy work better than epinephrine auto-injectors?
A: While neffy is a promising new treatment option, it has not been tested as a comparison to auto-injectors during anaphylaxis. (That would be unethical.) So we cannot say if it works just as well or better.
However, we do know that the amount of medication in the blood is the same for both. As we gather more real-world data, we will be able to answer these questions more definitively.
Q: Does neffy have an expiration date?
A: Yes, a neffy device is expected to last about 30 months. This is longer than auto-injectors, which typically last 12 to 18 months.
The nasal spray should be stored at room temperature, between 68 and 77 degrees Fahrenheit. ARS Pharma studies report neffy can maintain its potency and effectiveness in extreme heat (up to 122 degrees Fahrenheit) and cold better than auto-injectors.
Q: When is neffy expected to be available?
A: The epinephrine nasal spray neffy is now available. Ask your doctor or healthcare provider for a prescription.
The medication neffy represents a significant advancement in the treatment of severe allergic reactions. It’s a treatment option that could make a real difference in the lives of many people. Allergy & Asthma Network is committed to keeping you informed as neffy becomes widely available.
Learn more about anaphylaxis and epinephrine.
Reviewed by:
Purvi Parikh, MD, FACAAI is an adult and pediatric allergist and immunologist at Allergy and Asthma Associates of Murray Hill in New York City. She is on faculty as Clinical Assistant Professor in both departments of Medicine and Pediatrics at New York University School of Medicine.