Called Neffy, it was approved by the FDA on 8/9/24. Neffy is a single dose nasal spray administered into one nostril. As with epinephrine injection products, a second dose (using the new nasal spray to administer neffy in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen.
The cost of neffy is anticipated to be around $199 for two doses via digital pharmacy sites like GoodRx and around $25 for commercially insured patients through a co-pay savings program.
Neffy’s approval was based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of neffy or approved 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. A study of neffy in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received neffy.
However, many patients may choose to still go with the epipen injection option for one main reason... with anaphylaxis, a stuffy nose may occur which may limit how well the epinephrine gets absorbed into the body. The initial studies performed on this product was only done on normal healthy adults WITHOUT anaphylaxis. There is mention of research showing that epinephrine is effectively absorbed into the circulation in patients who had allergen induced nasal congestion, but the details on this finding is sparse.
Before I would unreservedly recommend Neffy to my patients, I would like to see published comprehensive studies that show how quickly and fully epinephrine gets absorbed into the blood stream in patients with a very stuffy and runny nose (say from having bad allergies) which would mimic the adverse nasal conditions that may occur with anaphylaxis.
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