(NEW YORK) — A patch that sits on a person’s skin could help reduce the risk of severe allergic reactions in toddlers with peanut allergies, according to the newly published results of a small clinical trial.
The results, published Wednesday in the New England Journal of Medicine, found that toddlers who wore the patch for 22 hours a day for one year were able to tolerate the equivalent of one to four peanuts, meaning their sensitivity to peanuts had been reduced.
The phase 3 trial, led by a physician at Children’s Hospital Colorado, involved more than 300 children ages 1 to 3, all with peanut allergies.
The patch, named Viaskin, works by releasing small doses of peanut protein powder that are absorbed into the skin, thereby exposing the child to peanuts, according to DBV Technologies, the biopharmaceutical company behind Viaskin.
The Viaskin patch is designed to be switched out daily and worn between the shoulder blades.
The latest medical guidelines recommend that if a child does not have any eczema or food allergy, a parent may start exposing them to peanut-containing foods as young as 6 months of age in order to reduce the risk of developing a peanut allergy, according to the American College of Allergy, Asthma & Immunology.
Peanuts are one of the eight foods that “account for the most severe allergic reactions in the United States,” according to the Centers for Disease Control and Prevention . A food allergy affects 1 in 13 children in the U.S., according to the CDC.
Dr. Matthew Greenhawt, a lead author of the trial, said in a statement released by DBV Technologies that the patch has “the potential to give new hope” to families.
“This publication shows that, if approved, the Viaskin Peanut patch has the potential to give new hope to toddlers and their families who currently have no approved treatment options and must instead rely on avoidance, which can severely impact quality of life,” Greenhawt said. “The EPITOPE data are a meaningful advancement in potentially offering the first-ever FDA approved treatment option for peanut-allergic toddlers.”
DBV said in a statement it is “advancing regulatory efforts” to get Viaskin approved for children ages 1 to 3.
People with a peanut allergy must, in most cases, avoid peanut products in their diet and carry an injectable epinephrine — also called an EpiPen — for immediate use.
There is currently not an approved treatment for children under age 4 with a peanut allergy.
In 2020, the Food and Drug Administration approved the first drug designed to minimize the frequency and severity of a child’s allergic reaction to peanuts.
The drug, Palforzia, is a powder that comes in the form of pull-apart capsules. The powder is emptied from the capsules at the time it is taken and mixed into a semisolid food, like applesauce or yogurt, according to the FDA.
Palforzia is taken in three phases over the course of several months.
It is currently approved only for kids ages 4 to 17 with a “confirmed diagnosis of peanut allergy,” according to the FDA.
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