The First-Ever Nasal Spray for Anaphylactic Shock Gets FDA Approval

The U.S. Food and Drug Administration (FDA) has approved the world’s first nasal spray drug, neffy (epinephrine nasal spray), for the treatment of Type I anaphylaxis. Approved on August 9, 2024, this adrenaline nasal spray offers a new option for treating severe allergic reactions in adults and pediatric patients weighing at least 30 kg. Further, this approval introduces a significant alternative for patients who delay treatment due to an aversion to injections.

Neffy Matches the Efficacy of Traditional Injectable Treatments

Anaphylactic shock, a severe and life-threatening allergic reaction, often impacts multiple parts of the body. Common allergens, such as certain foods, medications, and insect bites, trigger this reaction. Symptoms typically appear within minutes of exposure and include hives, swelling, itching, vomiting, difficulty breathing, and loss of consciousness. Previously, epinephrine was the only life-saving treatment for anaphylactic shock, but it was only administered through injection. However, with the introduction of neffy by ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), there is now an alternative delivery method available. This approval tackles the issue of injection fear, especially among children. By providing a less intimidating treatment option, it represents a significant advancement in managing this life-threatening condition.

Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, stated, “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 the rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.”

The approval of neffy was based primarily on four clinical trials involving 175 healthy adults without anaphylactic shock. These trials compared the concentration of epinephrine in the blood from neffy to that of approved injectable epinephrine products. Research shows that neffy achieves comparable blood concentrations to these injectable products. Additionally, neffy has comparable effects on increasing blood pressure and heart rate, which are crucial for treating anaphylactic shock. Furthermore, in children weighing more than 30 kg, the epinephrine concentrations following neffy were similar to those found in adults.

Precautions for Using Neffy and FDA Fast Track Designation

Neffy is a single 2-milligram dose of nasal spray administered into one nostril. If symptoms do not improve after one spray, users must apply another spray into the same nostril and seek medical assistance while closely monitoring the progression of shock. Although neffy offers a new non-injectable treatment option, users should be aware of nasal conditions that may affect drug absorption, such as nasal polyps or prior nasal surgery. These patients should consult their healthcare professional about continuing use of injectable epinephrine products. Additionally, neffy provides warning signs and precautions for patients with specific co-morbid conditions and sulfite allergies.

Common side effects of neffy include throat irritation, tingling in the nose, headache, nasal discomfort, nervousness, tingling, fatigue, tremors, runny nose, itchy nose, sneezing, abdominal pain, sore gums, numbness in the mouth, nasal congestion, dizziness, nausea, and vomiting. 

Current FDA Approval Initially Delayed for Additional Data and Repeat-Dose Study; Neffy Aims to Resolve Challenges in Epinephrine Delivery and Cost

Friday’s approval followed a delay in September when the FDA requested additional data from the drugmaker. The agency required a repeat-dose study of neffy to demonstrate its efficacy compared to existing epinephrine products. ARS Pharmaceuticals had previously submitted data primarily from healthy individuals or those with mild allergies, not anaphylaxis. Additionally, the data lacked sufficient safety information, no formal clinical efficacy trial was conducted, and results varied across trials. However, after appropriate information was provided, the FDA granted ARS Pharmaceuticals Fast Track designation for the drug, marking a significant milestone in the treatment of anaphylactic shock. 

Developing an epinephrine nasal spray has been challenging due to the drug’s poor nasal absorption. ARS presents neffy as a more convenient alternative to auto-injectors, which have long been the only quick treatment for severe allergies. Epinephrine, the same as adrenaline, has treated anaphylaxis for a century, but existing treatments face supply, cost, and design issues that neffy aims to resolve. Neffy is expected to cost no more than $199 per pair for those without insurance or with high-deductible plans, while commercial insurance users can reduce copays to $25 per two-pack with coupons. Unlike other epinephrine products, which have faced supply shortages and quality control issues, neffy uses a simple spray device similar to those for Narcan and other products, offering a reliable, one-handed delivery system in a container about the size of a tea bag.

Author

Bernice Lottering