FDA approves first nasal spray for anaphylaxis

On August 9, the FDA approved "neffy," the first-ever nasal spray for the emergency treatment of anaphylaxis. This approval represents a significant advancement in managing severe allergic reactions, offering an alternative to traditional epinephrine injections.

Anaphylaxis is a severe, life-threatening allergic reaction that requires immediate intervention. Traditionally, the only treatment has been epinephrine injections. However, the fear and hesitation associated with injections, especially among children, have often delayed timely treatment. With neffy, patients now have a needle-free option.

“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” said 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. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.”

Neffy is a single-dose nasal spray administered into one nostril. If symptoms do not improve or worsen, a second dose may be given using a new spray in the same nostril. This ease of use is expected to encourage more timely treatment during emergencies.

The FDA's approval of neffy is based on four studies involving 175 healthy adults. These studies compared the blood concentrations of epinephrine following the administration of neffy to those of approved epinephrine injection products. Results demonstrated comparable epinephrine levels and similar physiological responses, such as increased blood pressure and heart rate.

A study also confirmed that children weighing more than 66 pounds showed similar epinephrine concentrations to adults after using neffy. This ensures that the nasal spray is effective across different age groups, broadening its applicability.

Introducing a nasal spray form of epinephrine is expected to address significant barriers in treating anaphylaxis. Many patients, particularly children, often avoid or delay using injections due to needle phobia. Neffy's nasal spray format offers a more approachable solution, potentially increasing compliance and reducing risks associated with delayed treatment.

While neffy presents a promising alternative, it comes with considerations. Certain nasal conditions, such as polyps or a history of nasal surgery, may affect absorption. Neffy also includes warnings for individuals with specific coexisting conditions and those allergic to sulfites.

The most reported side effects of neffy include throat irritation, nasal discomfort, headache, and a tingling sensation in the nose. Other effects may include dizziness, nausea, and fatigue. Despite these, the benefits of rapid and easy administration could outweigh the minor discomforts for many users.

Neffy's approval is poised to transform the healthcare community's approach to managing anaphylaxis. By offering a non-invasive method of delivering life-saving medication, healthcare providers can better support patients who may hesitate with traditional methods.

The FDA's decision to grant Fast Track designation to neffy underscores the urgent need for innovative solutions in allergy treatment. This approval meets an unmet need and aligns with ongoing efforts to improve patient outcomes and accessibility.