FDA Approves First Nasal Spray for Emergency Allergic Reactions

On August 9, 2024, the U.S. Food and Drug Administration (FDA) approved Neffy, an epinephrine nasal spray developed by ARS Pharmaceuticals, for the emergency treatment of type I allergic reactions in adults and children weighing at least 30 kg. This marks the first non-injection epinephrine product approved by the FDA.

“Some individuals, particularly children, may delay or avoid treatment due to fear of injections. The epinephrine nasal sprays helps to reduce barriers to treating allergic reactions.” said Kelly Stone, Deputy Director of the Division of Pulmonary, Allergy, and Critical Care at the FDA’s Center for Drug Evaluation and Research.

Severe allergic reactions, known as anaphylaxis, are rapid, life-threatening hypersensitivity reactions that can affect multiple systems in the body. Common allergens that can trigger these reactions include certain foods, medications, and insect stings. Symptoms typically appear within minutes of exposure and may include, but are not limited to, hives, swelling, itching, vomiting, difficulty breathing, and loss of consciousness. Epinephrine is the first-line emergency treatment for severe allergic reactions, which has previously only been available in injectable form.

According to the World Allergy Organization’s 2013 "White Paper on Allergic Diseases," the global prevalence of allergic diseases is estimated to be between 10% and 40%. This includes 400 million individuals with allergic rhinitis, 300 million with bronchial asthma, and between 200 million to 250 million with food allergies, along with 150 million experiencing drug allergies. As noted on the ARS Pharmaceuticals website, approximately 40 million people in the U.S. experience severe type I allergic reactions, primarily triggered by food, venom, or insect stings. However, only about 3 million have a prescription for epinephrine, and 80%-90% of prescribing physicians do not carry or administer epinephrine in a timely manner.

ARS Pharmaceuticals announces that Neffy is a single-dose nasal spray containing epinephrine, administered by spraying into one nostril. If symptoms persist or worsen, a second dose can be used in the same nostril after five minutes. Common side effects include throat irritation, headache, anxiety, fatigue, sneezing, abdominal pain, nasal congestion, dizziness, nausea, and vomiting.

The FDA's approval of Neffy is based on four studies involving 175 healthy adults without allergic reactions. These studies demonstrated that the levels of epinephrine produced in the bloodstream, as well as increases in blood pressure and heart rate, were comparable to those seen with injectable counterparts. Additionally, a study involving children weighing over 66 pounds indicated that the epinephrine concentrations in children using Neffy were similar to those observed in adults using the same medication.

ARS Pharmaceuticals aim to ensure that everyone can access Neffy at an affordable cost. Currently, the co-payment is set at $25, which is lower than the average co-payment of $40 for existing generic products. Additionally, ARS Pharmaceuticals will provide assistance for those in financial need. A co-payment is a common concept in U.S. healthcare, referring to the fixed amount that patients must pay out-of-pocket when receiving medical services.