On Aug. 9, 2024, the Food and Drug Administration (FDA) approved neffy®, an epinephrine nasal spray to treat anaphylaxis, a severe allergic reaction. It has been approved for adults and children who weigh about 66 pounds or more (30 kilograms).

Neffy is a single-dose nasal spray to be given in 1 nostril. You can give a second dose (using a new nasal spray to administer neffy in the same nostril) if symptoms don’t get better or get worse. You may need to get emergency medical care to monitor the allergic reaction in case you need more treatment.

Until now, epinephrine has only been available in devices that use needles. A nasal spray gives people managing allergies more options. And as we told the FDA in May of last year, people at risk of anaphylaxis deserve to have a choice in treatment.

On Sept. 19, 2023, the FDA asked for another study on neffy that focused on adults. This approval follows that study. A study of neffy in children weighing more than 66 pounds showed that epinephrine amounts in children were similar to adults who received neffy.

Epinephrine is the first-line treatment for severe allergic reactions. But far too often, people are not using or getting epinephrine when needed. In a study the Asthma and Allergy Foundation of America (AAFA) conducted in 2019, almost 3 out of 4 people said they didn’t use epinephrine for their most recent severe allergic reaction.

Epinephrine nasal spray may remove some of the barriers that prevent people from using epinephrine. The needle-free device removes the fear of needle-based injections and may be easier to use. This may increase confidence among people managing life-threatening allergies.

Innovation is one of our foundation’s core values and we are excited by this new treatment for severe allergic reactions. We will continue to advocate for research that supports our community.

Read the FDA press release to learn more about neffy.

Here are some answers to common questions about neffy.

When will I be able to get neffy?

The epinephrine nasal spray should be available around mid-October. Starting September 4, 2024, you can preorder neffy by visiting neffy.com and clicking the “Getneffy now” button at the top of the homepage. The company expects to start shipping pre-orders at the end of September.

How much will neffy cost? Will it be covered by insurance?

If you have commercial insurance (for example, through your job), you can pay $25 for each filled prescription of 2 devices using ARS Pharma’s copay savings program.

If you don’t have insurance coverage, your plan doesn’t cover neffy, or if you have a high-deductible plan, you can pay a cash price of $199 for 2 doses of neffy using BlinkRx. BlinkRX is a digital pharmacy service that is available to you at no added cost.

This cash price is also available if you use retail pharmacy discounts through GoodRx.

The ARS Pharma Patient Assistance Program (PAP) may provide neffy at no cost if you:

• Are a U.S. resident
• Don’t have enough insurance
• Don’t have insurance
• Meet certain eligibility criteria
• Have tried all other options to help pay for neffy

Visit neffy.com or call 1-877-696-3339 for more information.

How many doses does 1 neffy device have?

Each device offers a single dose. Each prescription comes with 2 single-use devices.

Does neffy still work if my nose is congested or if I have a cold?

Clinical tests suggest that upper respiratory tract infections, allergic rhinitis, and infectious rhinitis do not affect how much epinephrine you get or how much you absorb after giving neffy.¹

Talk with your doctor for more information on conditions that may affect how well neffy works. You can also visit neffy.com for more information.

Is neffy as effective as an epinephrine auto-injector?

Yes. Four tests in adults showed that the epinephrine nasal spray works as well as an auto-injector for anaphylaxis. The FDA approved neffy after more testing confirmed how well it works.

• neffy affected systolic blood pressure within 1 minute of dosing.²
• People who gave themselves neffy had responses that were the same or higher than injected epinephrine given by health care providers.³
• In a study of 90 patients, 100% correctly gave neffy to themselves or someone else.⁴
  
  

Is neffy affected by temperature?

Neffy should NOT be frozen. If frozen, neffy will not deliver epinephrine while frozen. These devices can temporarily handle heat up to 122 F. But it is best to keep neffy between 68 - 77 F. The nasal spray is good for 30 months. Studies showed it was still good after thawing if accidentally frozen.^2,5

How quickly does neffy expire?

The expiration date of a medicine is based on when that medicine was made. The expiration date of the device you pick up at your pharmacy will depend on how long ago it was manufactured. The nasal epinephrine spray is good for 30 months.²

Who can use neffy?

Neffy has been tested in adults and in children weighing 66 pounds or more. ARS Pharma plans to file another application with the FDA for neffy for children who weigh between 15 to 30 kilograms later in 2024.

How do I use neffy?

• Remove one neffy device from blister pack.
  
  
• Hold the device with your thumb on the plunger and fingers on either side of the nozzle. Do not press the plunger yet. You do not need to spray a test spray. Each device only has one spray.
  
  
• Insert the nozzle into a nostril until your fingers touch your nose. You can be in any position (sitting, standing, lying down).
  
  
• Keep the nozzle pointing straight toward your forehead. Don’t angle the nozzle toward your nasal septum (wall between the nostrils) or the other wall of your nose.
  
  
• Press the plunger firmly until it snaps up and liquid sprays out. You do not need to sniff to inhale the medicine. If any liquid leaks out of your nose, you may need to give a 2nd dose if you still have symptoms.
  
  
• If you still have symptoms, use the second neffy device for a 2nd dose. You can give it 5 minutes or more after the 1st dose in the same nostril.

See neffy.com for more information and videos on how to use neffy.

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Medical Review: August 2024 by Mitchell H. Grayson, MD

References
1. Oppenheimer J et al. Pharmacokinetics/Pharmacodynamics of Intranasal Epinephrine in Subjects with and without Upper Respiratory Infections Presented at the American College of Allergy, Asthma and Immunology (ACAAI); November 9-13, 2023; Anaheim, CA.
2. ARS Pharma Data on File.
3. Casale TB et al. Pharmacokinetics of Self-Administration of ARS-1 (neffy® Nasal Spray) 2.0 mg Versus Manual Intramuscular (IM) Epinephrine 0.3 mg by Health Care Provider (HCP). Presented at: American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting; February 24, 2023; San Antonio, TX.
4. Lowenthal R et al. Self-Administration of Intranasal Epinephrine (neffy) Using the Aptar Unit Dose System Compared to EpiPen and Symjepi. Presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology; February 25-28, 2022; Phoenix, AZ.
5. neffy Epinephrine Nasal Spray Full Prescribing Information. ARS Pharma. 06-2024.