An EpiPen is essential for managing anaphylaxis in individuals with severe allergies. After 35 years, a new needle-free treatment option provides an innovative alternative for handling severe allergic reactions, potentially improving daily routines and safety.
By Genni Burkhart
For people with severe, life-threatening allergies, carrying an EpiPen is critical to managing their condition. These auto-injection devices contain epinephrine, which rapidly counteracts the symptoms of anaphylaxis, a severe allergic reaction that can be life-threatening if not treated promptly.
The constant need to have these devices on hand can be a significant aspect of daily life for those affected, influencing their routines, activities, and even their sense of security.
For the first time in 35 years, there's a new, needle-free treatment option for severe allergic reactions.
Needle-Free Epinephrine
On August 8th, the FDA (U.S. Food and Drug Administration) approved neffy® (epinephrine nasal spray) 2 mg for the treatment of Type 1 allergic reactions, including anaphylaxis in adults and children weighing > 30 kg (66 lbs.).
neffy® is an intranasal epinephrine device for people with Type 1 allergic reactions to food, medications, and insect bites that could lead to severe life-threatening anaphylaxis.
Richard Lowenthal, Co-Founder, President, and Chief Executive Officer at ARS Pharmaceuticals, states, “This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies – a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many.
"Epinephrine treatment is only effective if available, readily usable, and administered appropriately. Our team has worked tirelessly to create an easy-to-carry, easy-to-use, needle-free device that offers peace of mind to patients and caregivers by enabling them to administer epinephrine quickly and confidently when needed.
"We thank the FDA staff for their partnership and support in the development of neffy® and are deeply grateful to the severe allergy community, including advocates, patients, parents, and healthcare professionals, for their contributions to the development of neffy® as an important, life-saving treatment.”
Injectable Limitations
According to information from ARS Pharmaceuticals' website, while epinephrine auto-injectors are highly effective, several limitations contribute to delays or omissions in administering treatment during emergencies. These limitations include the fear of needles, issues with portability, safety concerns related to the needle, device reliability, and complexity.
In the United States, approximately 40 million people suffer from severe Type I allergic reactions due to food, venom, or insect stings. However, only 3.3 million of these individuals have an active epinephrine auto-injector prescription, and only about half consistently carry their prescribed device. Furthermore, even when patients or caregivers have an auto-injector on hand, more than half either delay or fail to use it in an emergency.
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 in the FDA's press release on this subject, “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 rapid treatment of anaphylaxis. As a result, neffy® provides an important treatment option and addresses an unmet need.”
Precautions and Availability
neffy® comes with a warning for those with specific nasal conditions, including polyps or a history of nasal surgery, and underlying structural or anatomical nasal conditions - all of which can impact absorption. In addition, those with heart problems, kidney problems, low potassium levels, Parkinson’s disease, thyroid issues, high blood pressure, diabetes, and those who are pregnant or plan to become pregnant or breastfeed should consult with their healthcare provider to discuss this and all medications.
If symptoms do not improve or worsen after the first dose, a second dose can be administered in the same nostril using a new nasal spray. Patients should seek emergency medical assistance for further monitoring and treatment when necessary.
The drug should be available within eight weeks of FDA approval and costs around $25 for two single-use devices (with insurance) and a co-pay savings program.
In Conclusion
This new drug has the potential to significantly enhance access to epinephrine, particularly in environments where accidental exposure to allergens is most likely, such as restaurants and airplanes. Experts widely view the FDA approval of neffy® as a major victory for the food allergy community and for those who fear needles.
Prompt administration is key to effectively treating anaphylaxis, and with neffy®, one more barrier is removed. This advancement represents a critical step in ensuring that individuals at risk of severe allergic reactions have quicker and easier access to life-saving medication.
Author: With 14 years as a published journalist, editor, and writer, Genni Burkhart's career has spanned politics, healthcare, law, business finance, technology, and news. She resides in Northern Colorado, where she works as the editor-in-chief of the Incisor at DOCS Education.
