neffy Gets FDA Green Light: A Game-Changer for Severe Allergy Sufferers

ARS Pharmaceuticals just hit a major milestone—the needle-free epinephrine nasal spray neffy is now hitting pharmacy shelves across the U.S. after FDA approval in August 2024. Here’s what that means for the 40 million Americans dealing with severe allergic reactions.

The Price Point: Who Can Actually Afford This?

If you’ve got commercial insurance, eligible patients are looking at a $25 co-pay for two neffy devices through neffyConnect. No insurance? ARS is asking $199 for two doses. For those who qualify, the patient assistance program covers it completely free. That’s a significant shift in accessibility compared to traditional epinephrine auto-injectors.

Why neffy Stands Out: The Needle-Free Advantage

Here’s the real story: the biggest barrier to epinephrine use isn’t availability—it’s fear. Needle anxiety keeps millions from carrying or using auto-injectors when they need them most. According to Dr. Carlos Camargo from Harvard Medical School, over half of patients with epinephrine prescriptions either delay treatment or skip it entirely during emergencies.

neffy’s design flips this: It’s an intranasal spray, no needle involved. This needle-free delivery system makes it easier to carry (fits in pockets, purses), faster to administer in panic situations, and psychologically less intimidating. The result? Researchers anticipate better patient compliance and faster treatment response, potentially reducing emergency room visits.

Getting neffy: Multiple Pathways

You’ve got options. Schedule with your doctor for a prescription, or visit neffy.com and hit “Get neffy Now” for a virtual consultation with a licensed physician. Both routes connect to neffyConnect for access and financial support. Starting now, national retail pharmacies are stocking inventory and co-pay savings cards are downloadable at neffy.com.

The Market Opportunity

Of the 40 million Americans with severe allergies, only 3.3 million hold active epinephrine prescriptions—and of those, half never consistently carry them. That’s the untapped market ARS is targeting. By removing the needle barrier, neffy could move the needle on treatment rates.

Global Expansion and Pediatric Push

Beyond U.S. launch, the European Commission approved EUR neffy (adrenaline nasal spray) in August 2024 for anaphylaxis treatment. ARS expects European availability by Q4 2024. Meanwhile, the company filed a supplemental FDA application for a 1 mg pediatric formulation (for patients weighing 33-66 lbs.), broadening neffy’s reach to younger patients.

Key Details on neffy Epinephrine Spray

Current approval: 2 mg formulation for adults and children weighing 30 kg or more. The FDA indicated its use for emergency Type I allergic reactions, including anaphylaxis from food, medications, and insect venom.

Dosing protocol: Two neffy devices recommended at all times. If symptoms don’t improve or worsen after the first dose, administer a second dose 5 minutes later using a fresh spray in the same nostril.

Safety considerations: Works through nasal delivery, so absorption can be affected by nasal blockages or structural conditions. Patients with heart disease, hyperthyroidism, Parkinson’s, or diabetes should discuss with their doctor—epinephrine can interact with these conditions. Common side effects include throat irritation, headache, nasal discomfort, jitteriness, and tremor.

The Bottom Line

For allergy patients and caregivers, neffy represents genuine innovation in emergency treatment access. By ditching the needle from the epinephrine delivery mechanism, ARS is removing a psychological barrier that’s kept millions from carrying life-saving medication. Combined with aggressive pricing and patient support programs, this could reshape how severe allergies are managed in the U.S. and internationally.