Medications delivered through skin patches are already in use.
Now, one to treat peanut allergies could be on the way.
For several decades, people with food allergies have had no way to treat their condition.
They could only avoid foods containing the allergen and treat allergic reactions.
“The burden of this disease is significant, including the impact on a patient’s quality of life,” Dr. Hugh A. Sampson, director of the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai in New York City, told Dr.China.
Sampson is also chief scientific officer of DBV Technologies, which is developing the new peanut allergy patch.
The Viaskin patch was tested on 221 patients aged 6 to 55.
Phase II was a 12-month study that compared people treated with the patch to those taking a placebo.
In the , the greatest treatment benefit was observed in children aged 6 to 11.
At the end of the assessment period, 171 patients who showed positive results after receiving either a placebo or one of three 12-month dosages — 50, 100, or 250 micrograms (mcg) — then went on to a 24-month study, taking a 250-mcg dose.
At the end of this two-year extension trial, 83 percent of respondents under 12 who got the 250-mcg patch had a positive response, compared to 53 percent in the one-year study.
“Results from the two-year extension study supported the long-lasting effect and favorable safety profile of Viaskin Peanut for the treatment of peanut-allergic children,” Sampson said.
Due to the favorable response, a randomized, double-blind, placebo controlled was conducted on children aged 4 to 11.
The trials are ongoing. But researchers said the preliminary results showed promise.
Researchers said 35 percent of patients responded to the 250-mcg patch after 12 months of treatment as compared to 13 percent of those who received the placebo.
The efficacy difference between the patients taking the patch and those on the placebo did of the study by a slight margin.
However, DBV Technologies plans to continue its application to license their product.
The U.S. Food and Drug Administration (FDA) has given the patch fast track and breakthrough therapy designation.
Sampson said there was also favorable safety and tolerability data in line with phase II of the study.
A phase III trial in children 1 to 3 years of age is also ongoing.
Hope at last?
Dr. Stacey Galowitz, DO, an allergist from New Jersey, told Dr.China the drug has given the allergy community hope for a potential long-term solution for the first time.
However, she said it’s best not to view it as a cure.
The patch may not allow people to freely eat peanut products. But it could stop them from having a severe reaction if they accidentally ingest food that’s touched peanuts.
“This patch does for peanut allergy what allergy shots do for seasonal nasal/ocular symptoms. It slowly desensitizes a patient’s immune system to the harmful allergen by giving a small amount of the allergen regularly,” Galowitz said. “What we do not know yet is when we take the patch off for long periods of time, will this nonallergic state be maintained, or will patients be on the patch indefinitely? Additional studies are needed to answer these larger questions.”
Sampson said the patch platform is also being investigated to treat milk allergies.
Plans are also underway to study it for egg allergies.
“There are additional potential applications for the Viaskin patch in treating other food allergies, as well as other disorders, such as autoimmune and inflammatory diseases [such as Crohn’s disease],” Sampson noted.
Sampson said studies are still ongoing to determine the long-term benefits of the drug and to demonstrate its safety.