New nasal spray epinephrine approved by FDA
New nasal spray epinephrine approved by FDA
The less-scary-to-use spray could displace EpiPens
The U.S. FDA approved an epinephrine nasal spray in August, the first nasal spray approved to treat anaphylaxis.
The preparation will be marketed as neffy (all lowercase, so cute!), and is approved for adults and children weighing at least 30 kg (66 pounds).
Neffy was approved based on four studies in 175 adults that demonstrated similar concentrations of blood epinephrine after spraying neffy as with approved epinephrine injection products.
Randomized trials with placebo controls were considered too risky or inappropriate to undertake.
FDA originally rejected the application, contradicting its own advisory panel and asking for additional proof that the drug would work with repeat doses and in people with nasal congestion from allergic rhinitis.
The product can be sprayed as a single dose into one nostril. A second spray in the same nostril can be given if there is no improvement or if symptoms worsen.
One potential benefit of neffy is overcoming the hesitancy that children or their parents have with needle injections. This will undoubtedly be front and center in the sales pitch, although it’s unclear how often such hesitancy actually delays home treatment for anaphylaxis.
But, given the option of spraying nasally instead of jabbing a needle into their or their child’s thigh, most people would probably choose the spray.
Neffy is reported to only cost $25 for patients with commercial insurance for two single-use devices. That copay crushes EpiPen’s historically exorbitant pricing (which I predict will suddenly plummet, at least for patients with commercial insurance). The cash price of the new spray is reported to be $199.
The new epinephrine nasal spray was made available for purchase in the U.S. starting in August 2024.
PulmCCM has no relationship with the makers of this or any other medication.