The U.S. Food and Drug Administration (FDA) approved the first-ever epinephrine nasal spray, Neffy, for the emergency treatment of allergic reactions, including life-threatening anaphylaxis.
The new treatment, a needle-free alternative, could be used for managing severe allergic responses in children and adults, weighing at least 66 pounds, the FDA said in a news release.
Allergic reactions occur from an overreactive immune response to a substance that typically does not cause any harm. While most reactions are mild, sometimes the immune response escalates within seconds or minutes, leading to a life-threatening emergency known as anaphylaxis. Common signs include a drop in blood pressure, rapid or weak pulse, skin rash, hives, itching, difficulty breathing, nausea, and vomiting.
Anaphylaxis requires immediate medical attention, typically with an injection of epinephrine. Neffy offers a simpler alternative: a single dose of nasal spray administered into one nostril. If symptoms don't improve or worsen, a second dose can be given in the same nostril, similar to situations where a second epinephrine injection would be considered.
"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," Dr. Kelly Stone from the FDA's Center for Drug Evaluation and Research said in a news release.
The FDA granted approval based on four studies involving 175 healthy adults without anaphylaxis. These studies measured the blood concentrations of epinephrine after Neffy was administered and compared them with those from traditional epinephrine injection products.
"Results from these studies showed comparable epinephrine blood concentrations between Neffy and approved epinephrine injection products. Neffy also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in the treatment of anaphylaxis," the FDA stated.
When researchers conducted studies on children weighing more than 66 pounds, they found similar epinephrine concentration levels.
However, individuals with specific nasal conditions, such as nasal polyps or a history of nasal surgery, should consult a healthcare professional, as absorption might be affected, making an injectable epinephrine product more suitable. Also, experts caution against using epinephrine in people with certain coexisting conditions or allergic reactions associated with sulfites.
The expected side effects include throat irritation, tingling nose, headache, nasal discomfort, feeling jittery, tingling sensation, fatigue, tremor, runny nose, itchiness inside the nose, sneezing, abdominal pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea, and vomiting.
"Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option – an often painful and anxiety-inducing needle injection of epinephrine...FDA approval of Neffy means that patients with severe allergies finally gain a long-awaited, needle-free, easy-to-carry epinephrine delivery method that has the potential to reduce time to administration, which can lead to better clinical outcomes and improvements in quality of life for patients and their caregivers," Dr. Thomas B. Casale, Professor of Medicine and Pediatrics and Chief of Clinical and Translational Research in the USF Health Morsani College of Medicine's Division of Allergy and Immunology at the University of South Florida in Tampa, Florida, said in a news release from ARS Pharmaceuticals that manufactures Neffy.
