New Nasal Spray Shows Promise for Seasonal Allergy Sufferers—Here's What You Need to Know

A revolutionary nasal spray called neffy (epinephrine nasal spray) is moving closer to FDA approval after positive study results, potentially offering a game-changing alternative to traditional EpiPens for people with severe allergies by October 2024. ARS Pharma recently submitted their response to the FDA's Complete Response Letter, with encouraging findings from repeat dosing studies under nasal allergen challenge conditions.

What Makes This Nasal Spray Different?

Unlike traditional epinephrine auto-injectors that require a needle injection into the thigh during anaphylaxis—a severe, life-threatening allergic reaction—neffy delivers the same life-saving medication through the nose. This could be particularly beneficial for people who fear needles or have difficulty with injections during emergency situations. The nasal spray format may also be easier for caregivers to administer to children or adults experiencing severe allergic reactions.

How Does Epinephrine Work Against Severe Allergies?

Epinephrine is the gold standard treatment for anaphylaxis, which can occur from various allergens including peanuts, tree nuts, shellfish, bee stings, or medications. When someone experiences anaphylaxis, their immune system releases massive amounts of histamine and other chemicals, causing symptoms that can include:

• Breathing Problems: Severe swelling of the throat and airways that can block breathing
• Cardiovascular Collapse: Dangerous drops in blood pressure that can lead to shock
• Skin Reactions: Widespread hives, swelling, and flushing across the body
• Gastrointestinal Symptoms: Severe nausea, vomiting, and diarrhea that can worsen dehydration

Epinephrine works by counteracting these effects—it opens airways, raises blood pressure, and reduces swelling. The key is getting the medication into the bloodstream quickly, which is why the nasal delivery method represents such an important advancement.

What's the Timeline for Availability?

The company has indicated a potential PDUFA (Prescription Drug User Fee Act) date of October 2, 2024, which means the FDA could make their final approval decision by that date. This timeline depends on the FDA's review of the additional data ARS Pharma submitted, particularly the positive findings from their repeat dosing study that tested how well the nasal spray works when people are exposed to allergens through their nose.

For the millions of Americans living with severe food allergies, seasonal allergies that can trigger anaphylaxis, or other life-threatening allergic conditions, this nasal spray could provide a more user-friendly emergency treatment option. The ability to avoid needles while still receiving the same life-saving medication could improve treatment compliance and reduce anxiety around carrying emergency medications.