The Food and Drug Administration has approved the first alternative to the EpiPen and similar needle-free epinephrine autoinjectors for the treatment of anaphylaxis.
Neffy, a nasal spray that delivers a dose of epinephrine, is the first of its kind that is not delivered by injection. Until Neffy’s approval, the only way to stop a life-threatening allergic reaction was with an injection like the EpiPen, which comes pre-filled with a dose of medication.
“Anaphylaxis is life-threatening, and some people, especially children, may delay or avoid treatment because of fear of injections,” Kelly Stone, MD, PhD, assistant director of the Division of Pulmonology, Allergy, and Critical Care Medicine in the FDA’s Center for Drug Evaluation and research, according to the press release.
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“Availability of epinephrine nasal spray may reduce barriers to prompt treatment of anaphylaxis. As a result, Neffy provides an important treatment option and addresses an unmet need.”
The Mayo Clinic explains: “Anaphylaxis is a severe, life-threatening allergic reaction. It can happen seconds or minutes after you’ve been exposed to something you’re allergic to. Examples are peanuts or bee stings.”
Anaphylaxis “occurs in about one in 50 Americans,” according to the Asthma and Allergy Foundation of America, adding, “Many believe the rate is higher than that. It’s probably closer to one in 20.”
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The Mayo Clinic says symptoms include skin reactions (like hives), low blood pressure, nausea, fainting — and “narrowing of the airways and a swollen tongue or throat, which can cause wheezing and trouble breathing.”
Food allergies are on the rise, according to Food Allergy Research and Education, with 33 million Americans reporting at least one food allergy.
“Milk, eggs, peanuts, tree nuts, wheat, soy, fish and shellfish have been identified as responsible for at least 90 percent of serious food allergy reactions in the US,” the organization says.
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Peanuts are the most common cause of allergic reactions to food.
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In particular, peanut allergies are on the rise—and as the Mayo Clinic points out, “peanut allergy is the most common cause of food-induced anaphylaxis.”
“Even small amounts of peanuts can cause a serious reaction that can even be life-threatening.”
In January, a 25-year-old man with a nut allergy died of anaphylactic shock after eating cookies that didn’t list peanuts on the label, and last year a Texas man died after eating a taco that didn’t list peanut butter as an ingredient.
While no details have been released on when Neffy will be available, the FDA has granted the product Fast Track status, speeding up its release to the public.
Categories: Trends
Source: HIS Education