FDA Approves Neffy: First Nasal Spray for Emergency Allergic Reactions

The FDA has approved Neffy, the first nasal spray containing epinephrine for treating severe allergic reactions, including anaphylaxis. Clinical trials confirm its efficacy, showing that Neffy offers a needle-free alternative, which may increase its usage among those who fear injections. Results demonstrate that it is comparable to injectable epinephrine.

ARS Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Neffy, the only epinephrine nasal spray for emergency treatment. It is indicated for severe allergic reactions (Type I), including life-threatening anaphylaxis in both adult and pediatric patients. This approval marks the first time an epinephrine product has been available in a non-injectable form, specifically catering to patients weighing at least 30 kilograms who are at risk for life-threatening allergic reactions.

"Today's approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections. The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need," said Dr. Kelly Stone, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA's CDER.

Rigorous Testing Validates Neffy's Efficacy

The FDA’s approval was supported by robust clinical trials involving 175 healthy adults, which demonstrated that the absorption and effect of epinephrine delivered through Neffy are comparable to those of existing injectable options. 

These studies assessed epinephrine concentrations in the bloodstream post-administration and monitored vital responses such as increases in blood pressure and heart rate—both essential for treating anaphylactic reactions.

Further investigation also included pediatric patients over the threshold weight of 66 pounds, establishing that the drug's pharmacokinetics—how it moves into, through, and out of the body—did not differ significantly from adults. These results underscore Neffy's potential as a reliable alternative to injections.

“This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies – a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” said Richard Lowenthal, Co-Founder, President and Chief Executive Officer, ARS Pharmaceuticals. “Epinephrine treatment is only effective if available, readily usable, and administered appropriately.”

Usage and Precautions

Neffy is administered as a single-dose spray in one nostril. If symptoms persist or worsen, a second dose can be used in the same nostril with a new device. Despite its ease of use, it's crucial for patients to seek immediate emergency medical care after administration to ensure comprehensive treatment of the anaphylactic episode.

Certain precautions should be noted: Neffy's absorption might be less effective in patients with nasal polyps, previous nasal surgery, or other nasal conditions. Additionally, the product carries warnings for individuals with certain coexisting medical conditions or those who are sensitive to sulfites, which are included in the formulation.

Side Effects and Considerations

Patients using Neffy may experience side effects such as throat irritation, tingling in the nose, headache, nasal discomfort, and dizziness. These are generally mild but are important considerations for those choosing this new treatment option.

Anaphylaxis is a severe and rapid allergic response that can be triggered by allergens such as specific foods, medications, and insect stings. This condition requires immediate medical intervention due to symptoms that can escalate quickly to hives, swelling, difficulty breathing, and even loss of consciousness. Traditionally, the only life-saving treatment available has been through injection, which can be a significant hurdle for those with a phobia of needles.

As Neffy makes its way into the market, it represents a significant step forward in allergy management, promising to make emergency treatment for anaphylaxis more accessible and less daunting for those affected by severe allergies.