U.S. FDA Delays Approval of Needle-Free Alternative to EpiPen
In a surprising turn of events, the U.S. Food and Drug Administration (FDA) has chosen not to approve Neffy nasal spray, a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. The decision has disappointed many who were hopeful for another option to combat life-threatening allergic reactions.
The FDA advisory panel had voted in May to recommend the approval of Neffy for both children and adults. However, the FDA instructed the drug’s manufacturer, ARS Pharmaceuticals, to conduct another study before granting approval. ARS Pharmaceuticals expressed deep disappointment about the delay and emphasized the potential benefits Neffy could provide to patients at risk of severe allergic reactions.
Dr. Scott Sicherer, director of the Elliot and Roslyn Jaffe Food Allergy Institute at Mount Sinai in New York, expressed his disappointment, stating, “It is certainly disappointing as we hoped to have another option for people at risk of serious allergic reactions.”
Both Neffy and EpiPen deliver epinephrine, a hormone that relaxes the muscles in the airways and constricts blood vessels. Neffy is designed as a nasal spray, while EpiPen is administered through an injection into a large muscle. Symptoms of an anaphylactic reaction, such as difficulty breathing, hives, and nausea, can be mitigated by the swift administration of epinephrine.
A needle-free option like Neffy would have been particularly valuable for individuals with a fear of needles or anxiety about self-injections. However, experts stress the importance of carrying epinephrine at all times for those with severe allergies, regardless of the delivery method.
While the FDA’s decision to delay approval of Neffy is disappointing, it is crucial to prioritize the availability of life-saving medications like epinephrine. In the meantime, injectable epinephrine devices remain an option for individuals in need of immediate treatment.
As the consequences of severe allergic reactions can be fatal, experts strongly recommend carrying multiple doses of epinephrine. Dr. Payel Gupta, a medical spokesperson for the American Lung Association, advises, “Epinephrine is a life-saving medication, and every patient with a severe allergy should have the device on hand.”
It is important not to ignore potential allergic reactions but to administer epinephrine promptly. Dr. Scott Sicherer advises, “Don’t wait until you have trouble breathing or pass out. The medication is safe, effective, and though it may cause a little pain, it could save lives.”
For now, patients and healthcare providers must rely on the existing injectable epinephrine devices while ARS Pharmaceuticals works to complete the additional study requested by the FDA.