FDA approves nasal spray as the first needle-free option for anaphylaxis. BNC News
The Food and Drug Administration (FDA) has recently approved a groundbreaking nasal spray called Neffy, marking a significant advancement in the treatment of severe allergic reactions. This new spray, developed by ARS Pharmaceuticals, is the first needle-free emergency treatment for potentially life-threatening allergies, offering a much-needed alternative to traditional epinephrine auto-injectors like EpiPen.
Neffy is designed to treat anaphylaxis, a severe allergic reaction that can involve multiple body systems and require immediate medical attention. Anaphylaxis can be life-threatening, and it’s estimated to cause up to 200 deaths annually. This new nasal spray provides a simpler and potentially less intimidating option for managing such emergencies.
The nasal spray is intended for both adults and children who weigh at least 66 pounds. It delivers a single dose of epinephrine, the same crucial medication used in autoinjectors, but without the need for a needle. The Asthma and Allergy Foundation of America (AAFA) has welcomed this development, noting that it may help overcome some of the barriers associated with using epinephrine. For instance, children and others who fear needles might find Neffy to be a more user-friendly alternative.
Neffy’s approval comes after a series of studies involving 175 healthy adults, which measured how effectively the nasal spray delivered epinephrine compared to traditional injection methods. Although the FDA initially declined to approve the spray last year, requesting additional testing, it has now given the green light following positive recommendations from independent experts.
Richard Lowenthal, co-founder and CEO of ARS Pharmaceuticals, explained that using Neffy is straightforward. The device requires no preparation before use—much like Narcan, the nasal spray used to reverse opioid overdoses. Users simply place the device into the nostril and press the plunger, which releases the medication. The epinephrine is absorbed through the nasal mucosa, which is an advantage over traditional epinephrine delivered through a vial, as the nasal spray includes a special solvent that aids in the absorption of the medication.
While Neffy represents a major innovation in emergency allergy treatment, users should be aware of potential side effects. These include mild nasal discomfort, headaches, runny nose, nausea, moderate dizziness, vomiting, and mild throat irritation. Despite these possible effects, Neffy is expected to significantly improve access to emergency allergy treatment and provide a less daunting option for those managing severe allergies.
