Update: Viaskin Peanut has been designated a “breakthrough therapy” by the Food and Drug Administration – a status granted to help expedite the development and review of the medical skin patch treatment. According to company officials, this is the first treatment for food allergies that has received this type of fast-tracking label.
The peanut patch allowed nearly half of those with peanut allergy to eat peanuts without developing symptoms, according to recent trial results with the experimental treatment.
The patch, known by the brand name Viaskin Peanut, applies small amounts of peanut protein to skin daily, which desensitizes peanut-allergic patients to the allergen over time – a process known as epicutaneous immunotherapy.
“The patch is about the size of a small round Band-Aid and instead of having that gauze in the center, you have a small amount of peanut protein,” explained Dr. Hugh Sampson, director of the Jaffe Food Allergy Institute at Mount Sinai in New York and first author of the study. “The concept where you use this low amount of protein in a convenient, safe way could change the way we do immunotherapy,” says Sampson.
The preliminary study, presented at the AAAAI annual meeting in Houston, tested various doses of the patch on 221 patients, with severe peanut allergy. After a year of using the patch, participants, aged 6 to 55, were subjected to a peanut oral challenge to determine if they could now tolerate peanut protein. Half of the patients who used the high-dose (250 micrograms) peanut patch were able to safely consume at least 1 gram of peanut protein, or approximately four peanuts – 10 times the dose they tolerated at the beginning of the study.
“The results suggest that this is a very promising way to go forward,” said Sampson, highlighting that unlike other treatments, such as oral immunotherapy, nearly all participants complied to using the daily patch for the duration of the trial and no serious adverse reactions were reported.
When the patch is placed on skin, a small amount of humidity develops under the patch allowing the protein to permeate the skin’s outer layer and be transported to the lymph nodes, activating the desensitization process.
While tolerating four peanuts worth of protein is not the same as being able to eat a peanut butter sandwich, for the participants, it reduces the risk of reacting foods containing trace amounts of peanuts, says Sampson. “They still need to be vigilant, they need to tell people that they’re peanut allergic, but the chances of these low-level contaminations that lead to the reactions that we see would be largely taken care of,” he says.
Sampson sees the patch having the potential to alleviate much of the worry that comes with severe allergies. “I think the whole mindset would switch if we could really reassure people that they can tolerate these doses.”
Researchers noted that children aged 6 to 11 had the best response to the patch – which was developed by DBV Technologies in France. At a AAAAI meeting press event, Sampson postulated that increased doses for older patients may be needed to see a greater effect in future studies.
Viaskin patch products are also being tested for the treatment of milk and egg allergy.