The U.S. Food and Drug Administration (FDA) has approved the epinephrine nasal spray neffy for the treatment of type 1 allergic reactions, including anaphylaxis, according to a recently published press release from ARS Pharmaceuticals, the manufacturer of the product.
Type 1 allergic reactions include those that are caused by food, insect bites and medications. These reactions can, at times, be associated with the development of life-threatening anaphylaxis.
Severe allergic reactions are more common in patients with mast cell diseases such as systemic mastocytosis (SM). Because individuals with SM exhibit an excessively large number of mast cells, they are known to be at an elevated risk for anaphylaxis.
Read more about SM treatment and care
In adults and children weighing ≥30 kg (66 lb), the approval of neffy represents the “first significant innovation in the delivery of epinephrine in more than 35 years,” the company stated in the press release. Neffy is the first and only needle-free therapeutic option for patients and their families who are known to experience severe allergic reactions.
Type 1 allergic reactions result in approximately 500,000 emergency department (ED) visits annually in the United States. Of note, almost 60% of these individuals reported not having received epinephrine before they presented to the ED.
According to Thomas B. Casale, M.D., professor of medicine and pediatrics and chief of clinical and translational research at the University of South Florida (USF) Health Morsani College of Medicine’s Division of Allergy and Immunology, located in Tampa Florida, “In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment.”
Data from five primary registration studies with a 2-mg intranasal dose of epinephrine were used to support the approval of neffy. The epinephrine nasal spray fulfilled all of the defined clinical endpoints in the studies. Further, all pharmacokinetic and pharmacodynamic data were within the range of all approved epinephrine injection products.
Adverse events (AEs) reported in neffy clinical trials were generally mild without any meaningful nasal irritation or pain. There were no serious AEs reported in any of the clinical studies conducted.
“Anyone who has experienced or witnessed an anaphylaxis reaction knows it can be very stressful deciding when to inject epinephrine to themselves or a child and often delay,” stated Jonathan Spergel, M.D., chief of the allergy program at Children’s Hospital of Philadelphia. “We know that earlier administration is better, and for many, the needle is a barrier that causes dangerous hesitation.”
It is anticipated that neffy will be available in the United States within 8 weeks of its FDA approval.
