This month, the FDA approved a nasal spray version of the drug epinephrine, a potentially ground-breaking alternative to auto-injectors like EpiPen for people with serious allergies. The nasal spray, called neffy, is needleless and could provide a cheaper, less painful, more convenient option than EpiPen for adults and children who weigh more than 66 pounds. There’s just one problem: It hasn’t yet been tested on people having active allergic reactions.
“We’re very excited about this development but we do have serious concerns,” Dr. Robert Wood, director of Johns Hopkins Children’s Center’s Division of Allergy, Immunology and Rheumatology, and a Johns Hopkins professor of pediatrics, told NPR.
Epinephrine is the only treatment that can save the lives of people experiencing anaphylaxis, also known as anaphylactic shock — a severe, sometimes life-threatening allergic reaction with symptoms including shortness of breath, hives, a drop in blood pressure, and loss of consciousness. Anaphylaxis can be triggered by allergies to food, insect bites, and medications. EpiPens have been FDA-approved and widely used since the 1970s, and while a generic version of EpiPen became available in 2018, neffy is the first real alternative to injectable epinephrine that may be able to treat anaphylaxis.
In clinical trials, drugmaker ARS Pharmaceuticals found that a nasal spray version of the drug was safe and delivered the same amount of epinephrine into the bloodstream as an injectable version. However, it hasn’t been tested on people actually in anaphylactic shock because it would be unethical for researchers to trigger an allergic reaction and give some of their subjects a placebo. One of doctors’ major concerns about neffy is that during an allergic reaction, the nasal cavity can sometimes become blocked. That, they say, could stop the absorption of the epinephrine in neffy and allow the allergic reaction to continue.
However, if neffy is effective at treating anaphylaxis, it offers many benefits over EpiPens. Aside from being easier for many people to tolerate due to its lack of needles, it’s about half the size of an EpiPen and easily fits in a pants pocket. It also has a longer shelf life and is less sensitive to temperatures — neffy can be stored in heat or cold for months at a time, while EpiPens must be kept at room temperature or they begin to lose their effectiveness.
Doctors also note that there’s no danger if someone accidentally administers neffy incorrectly, while injecting an EpiPen into a blood vessel instead of a muscle can cause harmful or even deadly side effects.