Discover Neffy: The New Nasal Spray for Severe Allergic Reactions

Neffy: The First FDA-Approved Nasal Spray for Severe Allergic Reactions

What Does Neffy Mean?

Neffy is the brand name product for an epinephrine nasal spray from ARS Pharmaceuticals. It delivers 2 milligrams (mg) of epinephrine and is used for immediate treatment of life-threatening allergic reactions, including anaphylaxis. Anaphylactic reactions are rapidly progressing, multisystem allergic reactions that can be fatal due to respiratory collapse. Neffy is a life-saving medicine for people with severe allergies.

FDA Approval of Neffy

In August 2024, the U.S. Food and Drug Administration (FDA) approved neffy, the first epinephrine nasal spray for emergency treatment of life-threatening hypersensitivity reactions in adult and pediatric patients. Neffy is currently the only FDA-approved medication that delivers epinephrine without injection.

How to Use Neffy?

Neffy comes as a single-use nasal spray that is administered into the nostril. As with other epinephrine products, the package contains two doses and a second dose (using the second nasal spray) can be given if there is no clinical improvement in allergy symptoms or symptoms worsen after the initial treatment. The second dose should be administered in the same nostril as the first dose. 

Neffy is not a substitute for professional medical care. You should seek emergency medical assistance after using neffy in case further treatment is needed. 

Importance of Needle-Free Treatment Options

Epinephrine is a tried and tested emergency treatment for severe, life-threatening allergic reactions. It is commonly available to eligible patients as EpiPen, an auto-injector that delivers epinephrine by intramuscular injection. 

However, using an EpiPen can be tricky. You need to use the auto-injector in the middle of your upper outer thigh. Doctors advise patients to avoid injecting the medicine into a vein, the buttocks, or the fingers or toes. Correct use of the auto-injector involves holding it down firmly for a full 3 seconds to deliver the correct dose of medicine. Accidental use of the EpiPen anywhere except the middle of the outer thigh requires emergency medical care. It’s also necessary to hold the leg firmly while using the auto-injector to prevent injuries.

Neffy epinephrine nasal spray makes the life-saving drug available in a ready-to-use device, doing away with the need for an injection. This epinephrine nasal spray is a needle-free option and gives the severe allergy community a compact, easy to carry, and easy to use epinephrine delivery system. Neffy comes as a major advantage for people who are afraid or don’t like needles. 

Eligibility Criteria for Neffy Nasal Sprays

Neffy is approved for use in adults and children who weigh at least 66 lbs (30 kg) and who have a history of or are at risk of serious allergic reactions.

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Mechanism of Action

How Neffy Works To Treat Allergic Reactions

Neffy contains epinephrine, a medicine that is used to treat severe allergic emergencies including anaphylaxis. Anaphylaxis is a life-threatening hypersensitivity reaction that can happen within minutes. Common triggers include insect stings and bites, foods, medicines, and other causes. 

Neffy epinephrine nasal spray reduces or reverses the severe symptoms of anaphylaxis rapidly. It decreases throat swelling and opens up airways, making it easier to breathe. Epinephrine also helps to maintain blood pressure and heart function. In addition, it diverts blood flow away from the skin and helps to relieve hives and itching. It also prevents further release of histamine, the chemical that causes allergy symptoms. 

Comparison with Traditional Epinephrine Injections

Benefits of Epinephrine Nasal Spray Delivery

• Needle-free delivery method. Neffy epinephrine nasal spray is an easy-to-use, needle-free treatment option. In contrast, epinephrine auto-injectors such as EpiPen need to be injected into the upper outer thigh.

• Less painful: Neffy nasal spray does not require an injection and is less painful than the auto-injector.

• More convenient: Neffy is more convenient and easier to use than the epinephrine auto-injector.

• Lower risk of injuries: Neffy carries no risk of injuries from sharp needles, as is the case with injection epinephrine products.

• Lower cost: Most commercially insured patients will pay less for neffy than the list price. The cost of neffy may be lower than that of EpiPen.

• Longer shelf-life: Neffy has a shelf life of 30 months compared to 18 months for epinephrine auto-injectors.

Tips for Using Neffy Correctly

• Neffy is available in two packs of nasal sprays. It is highly recommended to always carry a whole package of neffy (two neffy nasal sprays) on you. You may need a second dose if your symptoms do not improve, get worse, or come back. 

• Neffy should only be administered in the nostril.

• Use neffy as soon as possible after developing signs and symptoms of an allergic reaction. 

• If needed, take a second dose of neffy in the same nostril after 5 minutes, but make sure you use the second neffy nasal spray, included in the package. 

• After using neffy, get emergency medical help in case further treatment is necessary. 

Common Side Effects of Neffy

Common neffy side effects include throat irritation, nasal numbness, nasal discomfort, headache, dizziness, jittery feelings, tiredness, tremors, runny nose, nasal pruritus (itchy nose), sneezing, nasal congestion, reduced sensation in the mouth, gingival pain (gum discomfort), abdominal pain, nausea, and vomiting.

Neffy may cause more serious side effects, such as potentially fatal ventricular fibrillation (ventricular arrhythmias are heart rhythm abnormalities) in a small patient population. You can report suspected adverse reactions to the FDA’s MedWatch program.

Availability and Cost

Is Neffy Available Over the Counter?

No, neffy is not OTC (over-the-counter). You will need a prescription from your healthcare provider to get neffy.

Is Neffy Available in the U.S.?

Yes, neffy is available in U.S. pharmacies. Discuss the risks and benefits of neffy with your doctor. A prescription for neffy is needed from your healthcare provider. 

Pricing Details and Insurance Coverage: How Much Does Neffy Cost?

The list price for a two-pack of neffy is $710. However, this life-saving medicine is covered by insurance and most commercially insured patients will pay less than the list price. 

Neffy Accessibility for Patients

To make neffy accessible and affordable for patients, ARS Pharma offers a patient Assistance Program called NeffyConnect. 

• For people who have commercial insurance that covers neffy, the price of neffy will be $25 for each prescription (two single-use neffy nasal sprays) via a co-pay savings program. 

• For people who don’t have insurance coverage or have a health plan that does not cover neffy, ARS Pharma will offer a cash price of $199 for two doses of neffy via a digital pharmacy service called BlinkRx which is available free of cost. 

• For uninsured or underinsured U.S. residents who meet certain eligibility criteria and have no other options, ARS Pharma may provide neffy free of cost. 

• You can also make savings on the cash price of neffy at retail pharmacies by using a free BuzzRx savings card or discount coupon. 

Contact ARS Pharmaceuticals Operations (NeffyConnect) at 1-877-MYNEFFY (1-877-696-3339) for more details.

Effectiveness and Comparisons

Clinical Trials and Results

The FDA approved neffy based on the results of four studies that enrolled 175 healthy adults without anaphylaxis. 

Comparison with Other Epinephrine Devices: Is Neffy As Good As EpiPen?

Crossover studies comparing neffy (2 mg epinephrine nasal spray) and EpiPen (0.3 mg epinephrine intramuscular injection) have shown that neffy is comparable to or better than injection products. These studies were done both in healthy subjects as well as patients with a history of Type I allergic reactions. Type 1 allergic reactions are immediate responses to allergens and cause rashes, hives, itching, swelling, wheezing, stomach cramps, rhinitis (inflammation of the nose), and flushing.

Studies have also measured blood epinephrine concentrations after patients administer epinephrine nasal spray (neffy) and other approved epinephrine injection products such as EpiPen. The results show that epinephrine blood concentrations are comparable in people who use neffy and those who use injection epinephrine products. 

In addition, neffy also causes a similar increase in heart rate and blood pressure as epinephrine injection products. Neffy has also been studied in children weighing more than 66 pounds (30 kilograms) and was found to result in increased epinephrine blood concentrations in children, similar to adults. 

Studies have compared the use of neffy in people with normal nasal conditions and those with upper respiratory tract infections, which can alter nasal mucosa due to edema and congestion. The results showed that upper respiratory tract infections had a minimal effect on the absorption of neffy. Neffy caused a similar increase in blood pressure in both groups (patients with upper respiratory infections and those with normal nasal conditions).

Patient and Caregiver Testimonials

Neffy is the first epinephrine product that is not administered by injection. It is being hailed as a “game-changer” by people who are at risk of severe allergic reactions. This needle-free option has been especially welcomed by those with trypanophobia (a fear of needles).

Implications for Allergy Treatment

Who Should Not Use Neffy?

Neffy may not be safe for people with certain medical conditions. Tell your doctor if you have the following:

• Underlying structural or anatomical nasal conditions

• Other nasal conditions

• Low potassium

• High blood pressure

• Diabetes

• Underlying cardiac disease (heart disease)

• Chest pain (epinephrine can aggravate angina pectoris)

• Renal impairment (kidney problems)

• Thyroid disorders

• Parkinson's disease

Women who are pregnant or breastfeeding and elderly patients should discuss the benefits versus risks of neffy with their healthcare professionals.

Also, give your healthcare provider a complete list of your medications, including prescription drugs, over-the-counter medications, dietary supplements, and herbal products. This can help avoid potential drug interactions between neffy and your other medicines. Be sure to mention:

• Other nasal sprays 

• Diuretics (water pills) 

• Antidepressants

• Antiarrhythmics (prescribed for abnormal heart rhythm)

• Medications for Parkinson's disease

• Heart medications (for example, if you are taking cardiac glycosides)

• Medications prescribed for thyroid disease

• Allergy medicines

Impact on Patient Compliance and Emergency Response

Neffy is the first FDA-approved intranasal epinephrine product for treating anaphylaxis. It is expected to increase patient compliance and reduce the risks of delayed treatment and needle-related safety concerns. Epinephrine administration with neffy during potentially life-threatening events is expected to ultimately lead to better clinical outcomes compared to intramuscular injectable products. Key benefits that can protect patients include:

• Ease of use of neffy (needle-free option) 

• Non-invasive method of delivering life-saving medication

• Reduced risks of injury due to incorrect auto-injector use

Future Developments in Allergy Treatments

EpiPen offers EpiPen JR for children weighing less than 66 lbs (30 kg). In the coming weeks, ARS Pharma plans to submit a supplemental new drug application to the FDA for approval of a 1 mg nasal spray for children weighing between 36 and 66 pounds (13.6 and 30 kgs). If approved, the lower dose of neffy may become available in 2025. 

Other innovative products under investigation include sublingual epinephrine, inhaled epinephrine, and needle-free epinephrine autoinjectors (EAIs). These products may help address patient fears about needles and other reasons for delayed use.

Expert Opinions and Endorsements

Neffy devices offer safer administration and ease of use. They can play a big role in empowering at-risk patients, but these new devices still need to gain the trust of healthcare providers and patients. 

Injectable epinephrine products such as EpiPen are the gold standard for serious allergic reactions. They are proven to be rapidly effective with well-known clinical outcomes. Time will tell if neffy has real-world effectiveness and reliability, especially when administering treatment in patients with asthma and nasal allergies (where nasal congestion could impair the absorption of the drug).

Nonetheless, neffy is rapidly gaining global approval, including a recent approval by the European Medicines Agency.