The US Food and Drug Administration has given the green light to the first nasal spray epinephrine drug, Neffy, for the treatment of severe allergic reactions known as anaphylaxis. This approval provides a needle-free alternative to traditional EpiPens and similar medications, offering a more convenient option for adults and children weighing over 66 pounds.
Neffy is administered as a single dose sprayed into one nostril, with the option for a second dose if necessary. Studies have shown that Neffy provides comparable levels of epinephrine in the blood, as well as similar increases in blood pressure and heart rate, to injectable epinephrine.
Individuals with nasal conditions or who have had nasal surgery may not absorb Neffy effectively and should consult with a healthcare provider about the best treatment option for them. Common side effects of Neffy include throat irritation, tingling nose, headache, nasal discomfort, and feeling jittery.
Anaphylaxis, a life-threatening condition often triggered by medications, foods, or insect stings, requires prompt treatment to prevent serious complications. Neffy's approval aims to reduce barriers to rapid anaphylaxis treatment, particularly for individuals who may hesitate due to fear of injections.
ARS Pharmaceuticals, the maker of Neffy, plans to make the medication available in the US within eight weeks. The company has implemented pricing strategies to ensure affordability, with out-of-pocket costs capped at $25 for those with commercial insurance and a $199 option for individuals without insurance coverage or facing high costs.
Healthcare professionals and experts in the allergy community have welcomed the approval of Neffy, emphasizing its potential to save lives by providing a needle-free and pain-free alternative for anaphylaxis treatment. The company also intends to seek FDA approval for a lower-dose version of Neffy for children weighing between 33 and 66 pounds.
With the availability of Neffy, individuals with anaphylaxis and their caregivers now have a more accessible and user-friendly option for emergency treatment, similar to the impact of nasal-spray naloxone in opioid overdose situations. The FDA's approval of Neffy marks a significant advancement in anaphylaxis management, offering a safer and easier-to-use alternative for millions of individuals at risk of severe allergic reactions.
