A needle-free option for anaphylaxis
The U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) on Wednesday for the emergency treatment of severe allergic reactions. The product is the first epinephrine auto-injector alternative that does not use a needle. It delivers a 2mg dose of epinephrine as a fine mist sprayed into one nostril.
ARS Pharmaceuticals said the spray will be available by prescription starting in August, priced at $199 per two-pack — roughly the same as generic EpiPen options. A second dose can be given if symptoms do not improve after five minutes.
Clinical trial data supports approval
The FDA based its decision on two phase 3 trials comparing neffy to injected epinephrine. The nasal spray achieved similar peak blood concentrations and time-to-maximum concentration as injections. Common side effects included nasal irritation, headache, and mild throat discomfort — none requiring medical intervention.
Dr. John Kelso, an allergist at Scripps Clinic who advised on the trials, called the approval "a game-changer for patients who avoid carrying epinephrine because of needle anxiety." Surveys suggest up to 25% of people prescribed auto-injectors do not carry them consistently, citing fear of needles as a top reason.
Expanding access and market impact
Allergy specialists expect neffy to expand access in schools, restaurants, and public venues that hesitate to stock injectable epinephrine due to training requirements. The spray requires no assembly and can be administered by someone with minimal instruction.
Mylan, which manufactures EpiPen, said it will continue marketing its products and notes that patients should still consult an allergist before switching. ARS shares rose 22% on the news.