The U.S. Food and Drug Administration (FDA) has approved the first nasal spray epinephrine drug, named Neffy, for treating severe allergic reactions such as anaphylaxis. This offers a needle-free alternative to traditional epinephrine injections like EpiPens.
Neffy is approved for use in adults and children weighing over 66 pounds and is administered as a single dose into one nostril, with a second dose possible if needed.
The device uses the same delivery system as Narcan, a nasal spray for opioid overdoses, according to ARS Pharmaceuticals, the company behind Neffy.
Dr. Kelly Stone from the FDA highlighted that the nasal spray option might help overcome the fear of injections, which can delay treatment in life-threatening situations like anaphylaxis.
The FDA’s approval was based on studies showing that Neffy produces similar blood concentrations of epinephrine and comparable effects on blood pressure and heart rate as injectable forms.
Despite this, the FDA advises that patients still seek emergency medical attention after using the spray, particularly if additional treatment might be needed.
Certain individuals with nasal conditions may not absorb Neffy effectively and should consult with their healthcare provider about the best treatment option.
Neffy will be available in the U.S. within eight weeks, priced at $710 for a two-pack. ARS Pharmaceuticals has outlined plans to make the drug affordable through various co-pay and assistance programs.
The company expects Neffy to appeal to the millions of people who avoid using injectable epinephrine due to needle fear. They also anticipate that the drug could be widely adopted, similar to Narcan, and be stocked in public places for emergency use.
ARS Pharmaceuticals is also seeking FDA approval for a lower-dose version of Neffy for smaller children and is optimistic that the new nasal spray will become a significant tool in managing severe allergic reactions.
