FDA Grants Approval for Use of Epinephrine Nasal Spray

FDA Grants Approval for Use of Epinephrine Nasal Spray

Hold onto your hats, because the FDA just threw us a massive curveball. They’ve approved Neffy, a nasal spray for severe allergic reactions—finally, a way to treat anaphylaxis without a needle.

This new nasal spray, Neffy, contains the same epinephrine as the trusty EpiPen but is administered through a single spray in one nostril. And yes, you read that right—needle-free!

The FDA’s Dr. Kelly Stone remarked in a statement, “Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection.”

Who Can Use Neffy?

Neffy is designed for individuals weighing at least 66 pounds, so it covers both adults and children in need, as long as they meet the weight requirements. The spray is a single dose, but a second dose can be administered if symptoms persist—just switch nostrils.

Emergency Considerations

While Neffy is a game-changer, it’s crucial to remember that immediate medical assistance may still be necessary. As the FDA notes, “Patients may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.”

Safety First

People with a history of nasal surgery or certain medical conditions should consult a healthcare provider before using Neffy. Similar to EpiPens, side effects like nasal irritation, throat irritation, headaches, and jitteriness are possible.

Cost and Availability

For those on commercial insurance, Neffy will cost around $25 a pop. Without insurance, it is expected to cost around $200 for two doses. The uninsured and underinsured might, in some cases, receive it for free, Dr. Céline Gounder said.

The introduction of Neffy could also reduce barriers to rapid treatment, especially for those who fear needles. If you’re one of those folks who flinch at the sight of a needle, this nasal spray might be your new best friend.

Conclusion

It seems that the FDA has finally approved a viable alternative to the EpiPen. During research, it has reportedly worked about as well as an EpiPen and is expected to become available in the coming months. So maybe now we can all breathe a little easier.

Sources

  1. FDA approves 1st needle-free alternative to EpiPens
  2. FDA approves first nasal spray for severe allergic reactions. Here’s what to know.
  3. US FDA approves nasal spray alternative to EpiPen for allergic reactions
  4. FDA Approves First Nasal Spray for Treatment of Anaphylaxis

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FDA put Neffy approval on hold last year pending further data:

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