A Peanut Allergy Powder Earns FDA Approval

peanuts and medication

Tim Grist Photography / Getty Images

Key Takeaways

  • The FDA has approved Palforzia to mitigate allergic reactions in those with a confirmed peanut allergy.
  • Palforzia, a powder made from peanuts, is intended to expose the body to specific amounts of peanut protein.
  • The medication needs to be taken daily and is not a substitute for an EpiPen.

The Food and Drug Administration (FDA) has approved a powder made of peanuts to lessen allergic reactions in those who have a confirmed peanut allergy. News of Palforzia's approval as an oral immunotherapy was detailed in the July 14 issue of the Journal of the American Medical Association. 

Palforzia is for people ages 4 through 17. It must be taken every day, and is not designed as a treatment for emergency events. Rather, it's intended to make any reactions—including anaphylaxis—less severe if someone with a peanut allergy accidentally consumes peanuts. People talking Palforzia should still avoid peanuts and peanut products.

What This Means For You

If you or your loved one has a peanut allergy, this FDA-approved powder may be a solution to help lessen allergic reactions to peanut exposure over time.

What Does Peanut Allergy Treatment Usually Look Like?

Peanut allergies are one of the most prevalent food allergies in the United States, affecting an estimated 2.2% of children. A peanut allergy can be a life-threatening condition and traditionally requires complete avoidance of peanut exposure to prevent a reaction.

In the event of an exposure to this legume, people with a confirmed allergy typically have an epinephrine pen (EpiPen) injector with them at all times to treat symptoms of a reaction.

While the EpiPen appears to work well to combat an allergic reaction, it does require an injection and can be nerve-wracking to use, especially on children.

Experts have previously suggested that early exposure to peanut proteins in infancy may reduce the risk of developing a peanut allergy. In theory, it could help build a tolerance to these proteins, especially in high-risk infants with a family history of allergy.

Since allergies are triggered by proteins and not other macronutrients, like carbohydrates and fats, protein is the focus in allergy risk reduction. The American Academy of Pediatrics (AAP) now states that infants should be exposed to peanut proteins early and often to reduce the risk of developing a peanut allergy.

In older children with an established peanut allergy, oral daily exposure of peanut protein with a compounded peanut product has been shown to lessen allergic reactions in previous studies.

Repeated, small peanut protein exposures can teach the body to stop labelling the protein as “foreign” and prevent an immune response (an allergic reaction).

How Palforzia Powder Works 

Palforzia is designed around the concept of building a tolerance to peanut protein. This oral powder should be taken continuously by the patient, and the dose is titrated to provide more peanut protein as time goes on. The early doses of Palforzia must be administered under a doctor’s supervision due to the increased risk of triggering an allergic reaction.

Dosing consists of three phases:

  1. Initial dose escalation: Patients are provided with increasing doses of peanut allergen powder 20 to 30 minutes apart in a single day in a healthcare setting.
  2. Up-dosing: Once the patient can tolerate 3 milligrams (mg) of the peanut powder, the up-dosing phase includes 11 increasing doses of up to 300 mg, taken once daily for two weeks per dose.
  3. Maintenance: Patients take 300 mg of the peanut powder daily.

Palforzia is supplied in capsules containing varying doses of the powder. To take the powder, the contents of the capsules are simply added to cold or room temperature food. 

In a clinical trial evaluating this powder, 496 children between 4 and 17 years old with a peanut allergy were treated with peanut allergen powder or placebo. These participants were then exposed to a larger amount of peanut protein (at least the amount found in one peanut). Results suggest that those who were given Palforzia tolerated the exposure better than the placebo group.

It is important for families to note that a one-year supply of this drug will cost over $10,000.

Is Palforzia Practical?

While it's exciting to know that there may be a way to reduce the severity of a reaction if accidental peanut exposure occurs, this new innovation does not excite all health experts.

"Overall, in its current state, Palforzia is not likely practical given the expense," Pegah Jalali, MS, RD, CNSC, CDN, a registered dietitian and adjunct professor at New York University, tells Verywell. "Plus, patients will still need to adhere to a strict peanut-free diet and carry an EpiPen.”

Jalali also wonders whether younger children will actually consume the powder.

"As a pediatric dietitian, I worry about the treatment, since the child needs to eat the powder mixed with food," she says. "We all know that you cannot force a child to eat something. [Researchers] only have data for what happens if you miss two days of therapy, not more."

Other Peanut Exposure Products

While they're not medications, other products exist to help build up a child's exposure and tolerance to peanuts, especially children considered high-risk.

“Parents and caregivers must determine how to provide these types of foods safely at such a young age," Stephanie Hodges, MS, MPH, RDN, a registered dietitian nutritionist and owner of The Nourished Principles, tells Verywell. "Early introduction companies, such as Lil Mixins, provide powders that contain common allergen foods, making it easier for parents to know how much should be given to the infant and how often."

Along with Lil Mixins, other food products like SpoonfulOne, Happy Family Nutty Blends, Square Baby baby food, and Puffworks peanut puff snacks are appearing in grocery stores to support families who want to follow the AAP's recommendation of early exposure.

7 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Peanut allergen powder (Palforzia)JAMA. 2020;324(2):192–193. doi:10.1001/jama.2020.3599

  2. Food and Drug Administration. FDA approves first drug for treatment of peanut allergy for children.

  3. Jiang J, Bushara O, Ponczek C, Warren J, Blumenstock J, Smith R, Gupta R. Updated pediatric peanut allergy prevalence in the United States. Ann Allerg Asthma Immunol. 2018;121(5): S.14. doi:10.1016/j.amai.2018.09.042

  4. Comberiati P, Costagliola G, D'Elios S, Peroni D. Prevention of food allergy: The significance of early introduction. Medicina (Kaunas). 2019 Jun 30;55(7):323. doi: 10.3390/medicina55070323

  5. Bingemann T. Practical peanut introduction. American Academy of Pediatrics Blog.

  6. Wasserman R, Hague A, Pence D, Sugerman R, Silvers S, Rolen J. Herbert M. Real-world experience with peanut oral immunotherapy: Lessons learned from 270 patients. J Allergy Clin Immonol Pract. 2019 Feb;7(2):418-426.e4. doi:10.1016/j.jaip.2018.05.023

  7. Vickery BP, Vereda A, Casale TB, et al; PALISADE Group of Clinical Investigators. AR101 oralimmunotherapy for peanut allergy. N Engl J Med. 2018;379(21):1991-2001. doi:10.1056NEJMoa1812856