BETHLEHEM, Pa. — A new way to ease allergic reactions soon will be on the market.
Until now, many people who suffer severe allergies had to use an EpiPen that delivers medication through an injection.
A new way to administer that medication and counter the reaction is here.
“Time is of the essence when you’re having a severe allergic reaction. It will put people’s minds at ease to have a needle-free option for their kids.”Dr. Robert Zemble, chief of Lehigh Valley Health Network's Division of Allergy.
The U.S. Food and Drug Administration recently approved an epinephrine nasal spray that can be used instead of the shot.
“Having another option for the delivery of epinephrine that can cause less anxiety among patients is helpful,” said Dr. Robert Zemble, chief of Lehigh Valley Health Network's Division of Allergy.
“Time is of the essence when you’re having a severe allergic reaction. It will put people’s minds at ease to have a needle-free option for their kids.”
The spray called "neffy" was developed by California-based ARS Pharmaceuticals Inc. It’s the first new way in 35 years to administer the drug that treats a severe allergic reaction.
The only lifesaving treatment
Anaphylaxis is a severe, life-threatening allergic reaction to insect bites, foods, medications or latex.
Symptoms may include a swollen throat or swollen areas of the body, wheezing, chest tightness, trouble breathing, trouble swallowing, unconsciousness and a variety of other symptoms.
Epinephrine is the only lifesaving treatment for anaphylaxis.
"Neffy provides an important treatment option and addresses an unmet need.”Dr. Kelly Stone, associate director of the division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research.
“The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis," said Dr. Kelly Stone, associate director of the division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research.
"As a result, neffy provides an important treatment option and addresses an unmet need.”
Stone said the new way to administer Epinephrine will help get the medication into the patient faster as a number of people, especially children, hesitate to use an epipen because of a fear of needles.
The pharmaceutical company said 25 million to 40 million people in the United States have experienced severe type 1 allergic reactions that may lead to anaphylaxis.
However, ARS said only about 3.3 million of them filled a prescription in 2021 for an epinephrine intramuscular injectable device, including autoinjectors.
New product available soon
ARS said about half of those 3.3 million people don't carry their devices because of the drawbacks that can result in patient and caregiver injury, hesitation and delays in administration principally because of apprehension and pain of needles.
That delay can lead to a life-threatening situation or the patient may need to be hospitalized.
It's estimated that tens of thousands of anaphylactic reactions occur each year.The Journal of the American Medical Association.
A problem with EpiPens that many patients have complained about over the years is the cost. A person with a high-deductible insurance or no insurance will pay $300 to more than $600 for a two-pack of the single-use auto-injectors.
ARS Pharma, said neffy will cost about $25 for two, single-use device with insurance and about $199 if the patient has to pay cash.
The new product is expected to be available in pharmacies within the next eight weeks.
FDA approved it for people who weigh 66 pounds or more. By the end of September, ARS plans to apply for approval of neffy for children who weigh 33-66 pounds.
It's estimated that tens of thousands of anaphylactic reactions occur each year, according to the Journal of the American Medical Association.
It's estimated that the risk of death among those who suffer a reaction is about 1%, which equates to 500 to 1,000 deaths annually.
