FDA Approves First Epinephrine Nasal Spray

What is Neffy?

On August 9th, Neffy, which was made by ARS Pharmaceuticals, is an epinephrine nasal spray that can be used as an emergency medication to treat Type 1 allergic reactions as well as life threatening allergic reactions. Neffy is a huge feat in reducing barriers in treating severe allergic reactions. Patients suffering from anaphylaxis and severe allergic reactions could only use an Epipen. Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said “Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,”.

What are Type 1 Allergic Reactions? Anaphylaxis?

An allergic reaction occurs when an individuals’ immune system reacts to the presence of a certain allergen, a normally harmless substance. Generally, the immune system defends the body against antigens. However, when certain individuals are exposed to allergens, the immune system can overreact. In essence, the body created immunoglobulin E when in contact with a specific allergen. The IgE binds to the allergy cells. When the IgEs find allergens, they take the allergen to the allergy cells. When they attach to a special receptor, the allergy cell releases histamine which causes allergy symptoms. 

Type 1 reactions are the most widely recognized form of reaction. During a type 1 allergic reaction, the body reacts to the allergen causing effects in organ systems and swelling up individuals’ airways. Type 1 hypersensitivity reactions include food allergies, pollen-food allergies, latex allergies, etc. 

A severe allergic reaction is known as anaphylaxis. Anaphylaxis can be broken down into 4 stages:

1. Stage 1 : Mild - skin rash, redness, itching, hives.

2. Stage 2 : Moderate - spreading skin rash/hives, mild swelling in lips/tongue.

3. Stage 3 : Severe - difficulty breathing, extensive swelling, weak pulse, dizziness; in essence, the person is experiencing anaphylactic shock. 

4. Stage 4 : Life-threatening - losing consciousness, unable to breathe, inadequate blood flow, needs urgent medical attention.

The only way to treat anaphylaxis is through epinephrine which can be injected in the thigh through an Epipen. However, Neffy provides an alternative solution.

How does Neffy work?

Often, patients suffering from anaphylaxis and severe allergic reactions could only use an Epipen. Now, Neffy presents a pain-free, accessible, easy-to-carry, and needle-free option for patients. Neffy incorporates epinephrine, which is the only treatment for anaphylaxis. While antihistamines treat only a few systems, epinephrine can treat life-threatening reactions. Aforementioned, common symptoms of anaphylaxis is throat swelling, difficulty in breathing, drop in blood pressure, etc. Epinephrine, also known as adrenaline, can cause the heart to pump faster, cause deeper and faster breathing, and dilate the individual’s airways. Neffy also uses dodecyl maltoside, which is already a FDA-approved technology licensed from Neurelis. In essence, it enhances absorption through mucous membranes. Another FDA-approved technology that Neffy uses is the sprayer device, which is sold by Aptar Pharma, and used in Narcan nasal sprays. 

The approval of Neffy was based on four studies in 175 adults, without anaphylaxis.The study observed the epinephrine concentrations upon applying Neffy or approved epinephrine injections. Since results showed similar epinephrine blood concentrations and Neffy demonstrated similar increases in blood pressure and heart rate as epipens, the FDA approved the treatment. 

Similar to epipens, Neffy is a 2 mg single dose nasal spray that can be applied into one nostril in adults and children who weigh at least 66 pounds. If improvement is not eminent or symptoms worsen, a second dose should be applied. It is crucial to note that certain nasal conditions such as nasal polyps or history of nasal surgery can affect the absorption of Neffy. Also, Neffy comes with a warning of use for individuals with coexisting conditions and allergic reactions associated with sulfite. 

Citations

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“ARS Pharmaceuticals Receives FDA Approval of Neffy® (Epinephrine Nasal Spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis.” ARS Pharmaceuticals, 9 Aug. 2024, ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-Neffyr-epinephrine. Accessed 15 Aug. 2024.

Chipps, Bradley. “What Is Epinephrine? | Allergy & Asthma Network.” Allergy & Asthma Network, 31 Aug. 2022, allergyasthmanetwork.org/anaphylaxis/what-is-epinephrine/.

Cleveland Clinic. “Allergies: Symptoms, Reaction, Treatment & Management.” Cleveland Clinic, 21 Dec. 2022, my.clevelandclinic.org/health/diseases/8610-allergies.

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“FDA Declines to Approve Neffy Epinephrine Nasal Spray for Severe Allergic Reactions - CBS News.” Www.cbsnews.com, 20 Sept. 2023, www.cbsnews.com/news/fda-rejects-Neffy-epinephrine-nasal-spray-needle-free-epipen-allergic-reactions/.

https://www.facebook.com/Drugscom. “What Is Neffy (Nasal Epinephrine)?” Drugs.com, Drugs.com, 2024, www.drugs.com/medical-answers/question--Neffy-3573771/. Accessed 16 Aug. 2024.

Office. “FDA Approves First Nasal Spray for Treatment of Anaphylaxis.” U.S. Food and Drug Administration, 2024, www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis.

Tirrell, Meg. “First Nasal Spray Epinephrine Drug for Emergency Allergic Reactions Gets FDA Approval.” CNN, CNN, 9 Aug. 2024, www.cnn.com/2024/08/09/health/Neffy-nasal-spray-allergic-reactions/index.html. Accessed 16 Aug. 2024.