Breathe Life into Allergy Emergencies With Neffy Nasal Spray

Neffy nasal spray can serve as a painless substitute for Epipen.

Highlights:

The development of a nasal spray device called "Neffy" for delivering epinephrine is gaining traction
With a recent FDA advisory council vote in favor of its use. Final FDA approval is anticipated by mid-2023
Studies have shown that epinephrine administered through the nose via Neffy has comparable effects on heart rate, blood pressure, and anaphylaxis symptoms as injection-based devices like EpiPens

Thousands of people have tragically lost their lives due to anaphylaxis, a severe allergic reaction. Swift and effective treatment is crucial in such cases, and the current method involves administering epinephrine through needle-based devices like EpiPens.

However, a new nasal spray device called "Neffy" is poised to revolutionize epinephrine delivery. Recently, an external advisory council of the Food and Drug Administration (FDA) voted in favor of Neffy. The developers, ARS Pharmaceuticals, have stated that they anticipate final FDA approval by mid-2023.

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‘Anaphylaxis, a life-threatening allergic reaction, is a common occurrence, with an estimated impact on up to 5% of the population but this condition can now be combatted with neffy spray. #neffyspray #anaphylaxis #allergy’

The Nasal Spray vs. the EpiPen Injector

According to research data released by ARS Pharmaceuticals, administering epinephrine through the nose has the same impact on heart rate and blood pressure as an injection. This is significant because during anaphylaxis, heart rate decreases and blood pressure drops, making it challenging to maintain blood flow to vital organs.

The concept of a nasal device for epinephrine delivery is not entirely new in the medical field. Dr. Jessica Van Acker, a faculty instructor in the Department of Pharmacy Practice at Albany College of Pharmacy and Health Sciences, pointed out that the Unit Dose Sprayer device used in Neffy is the same technology employed for medications such as Narcan (naloxone) ().

"Epinephrine also prevents the release of histamine and other chemicals responsible for exacerbating an allergic reaction," explained Dr. Shuba Iyengar, MPH, co-founder and chief medical officer at Allermi. "For individuals with a history of anaphylaxis, it is an invaluable medical treatment," she added.

The nasal spray delivers a fine mist of epinephrine solution into the nasal cavity. The medication is rapidly absorbed through the moist lining of the nasal passages, which are rich in blood vessels. From there, epinephrine enters the bloodstream, binding to specific cell receptors to improve blood flow and reverse the symptoms of a severe allergic reaction, according to the manufacturer.

One advantage of epinephrine is its quick action. Symptoms typically begin to diminish within 5-10 minutes following injection into the muscle. Approximately 20% of patients may require a second dose of epinephrine, which can be repeated at 5–15-minute intervals if there is an insufficient response or no response at all. If symptoms worsen significantly, a second dose may be administered even sooner. Even if anaphylactic symptoms have subsided, it is important to seek follow-up care at a hospital if an allergic reaction requiring epinephrine occurs.

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For a person having severe allergies to any particular type of food, it is important for them to carry around EpiPen, which is nothing but the epinephrine injection that is life saving in such cases.

How Does an Epi Nasal Spray Work?

The FDA advisory committee thoroughly evaluated various pieces of evidence regarding the effectiveness of the Neffy device and any potential drawbacks. ARS Pharmaceuticals conducted multiple tests involving over 600 individuals to compare the impact of epinephrine administered through Neffy and EpiPen.

Ten to twenty minutes after administration, the levels of epinephrine in the body were comparable between the two devices. The effect on anaphylaxis symptoms was also similar. When a second dose of epinephrine was administered ten minutes after the initial dose, both Neffy and EpiPen demonstrated comparable effects on anaphylaxis. However, according to certain findings, the nasal device had a significantly greater impact on blood pressure ().

Moreover, none of the studies reported any major side effects from using the nasal device.

There was some concern about how nasal congestion might affect the absorption of epinephrine. While the nasal spray improved anaphylactic symptoms in individuals with a runny or blocked nose, the FDA report indicated that the committee ultimately voted in favor of the nasal device, with 16:6 supporting its use in older individuals and 17:5 supporting its use in children weighing more than 30 kg.

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Help for People who are Afraid of Needles

"Many people are afraid of giving injections, possibly due to pain or fear of administering it incorrectly," explained Dr. Tiffany Owens, an allergist/immunologist at The Ohio State University Wexner Medical Center. "The nasal spray device, on the other hand, is needleless and smaller than auto-injector devices," she added.

Dr. Owens further stated, "This may result in more patients carrying their epinephrine devices with them and, hopefully, decrease hesitancy to administer epinephrine."

Previous studies have shown that 52% of eligible individuals do not use their EpiPens. While the nasal spray device appears to be a viable alternative, Dr. Van Acker cautioned that it does not eliminate the risk of incorrect or improper use. "Patients should receive proper training and counseling on the use of any epinephrine rescue medication they have on hand," she emphasized.

The final decision is expected to be made this summer. FDA experts will review the provided clinical data and decide whether to authorize the product for public use. Dr. Van Acker expressed optimism about the future, stating, "Based on our knowledge of epinephrine and the data presented to the FDA, I believe Neffy could be approved for use and sale."

She further added, "Neffy's fast onset of action, favorable side effect profile, and analysis of BMI and drug exposure are compelling pieces of data supporting its approval."

Ultimately, it is up to the FDA to determine if additional data is necessary. Before being made available to the general public, the safety and efficacy of the nasal spray device must be thoroughly demonstrated. "The data shows promise, but we still need more information," Dr. Van Acker concluded.

What is Epinephrine?

"Epinephrine should be promptly administered as the first-line treatment for anaphylaxis," advised Dr. Kelly O'Shea, assistant professor in the Department of Internal Medicine at the Mary H. Weiser Food Allergy Center at the University of Michigan. Epinephrine is a hormone and neurotransmitter also known as adrenaline.

"It works by stimulating alpha-, beta1-, and beta2-adrenergic receptors, which are present throughout the body," explained Dr. Van Acker. By stimulating these receptors, epinephrine can alleviate anaphylaxis symptoms.

Symptoms of Anaphylaxis

Anaphylaxis is the most severe form of allergic reaction and typically occurs within seconds or minutes of exposure to an allergen.

Initially, symptoms may be mild, but they can rapidly progress to more serious manifestations. The reaction typically affects multiple body systems, resulting in a range of symptoms such as itching, redness, swelling of the neck, lips, and tongue, as well as stomach pain, nausea, and diarrhea.

While nut allergies are commonly associated with anaphylaxis, it can be triggered by almost any food. Peanuts, milk, shellfish, tree nuts, egg, fin fish, wheat, soy, and sesame are among the most common allergens.

References:

About Epinephrine - (https://pubmed.ncbi.nlm.nih.gov/29489283/)
Second Dose of Epinephrine for Anaphylaxis in the First Aid Setting: A Scoping Review - (https://pubmed.ncbi.nlm.nih.gov/33312799/)

Source-Medindia