Palforzia, a groundbreaking new drug, has just been approved by the Food and Drug Administration. The pill is meant for children who have severe reactions to peanuts and it works by helping to build tolerance to the nuts.
Though it is not a cure but still marks a step forward in reducing allergic reactions for kids ages 4 through 17, who have already been diagnosed with peanut allergies
The FDA acknowledges that peanut allergies are unpredictable and severe reactions can occur from even the smallest trace of peanuts.
The Palforzia pill is administered in three phases and is taken over time, but cannot be used in an emergency situation in the way that a treatment like an EpiPen is used.
The drug itself is a powder made from peanuts that comes in color-coded capsules for the first two phases. In the maintenance phase, the drug comes in a sachet. The powder can be mixed with semi-soft foods such as applesauce and yogurt before a child consumes it.
The first phase, called initial dose escalation, is consumed on a single day under the supervision of a medical professional, while up-dosing, the second phase, takes place over several months and involves 11 increased dose levels. The first dose in up-dosing would be given under a medical professional’s supervision as well, just to manage any potential severe allergic reactions. After that, the drug can be taken at home, as long as everything goes smoothly. Once the 11 doses in the second phase are completed, the third and final maintenance dose would then be administered daily.
The FDA tested both the effectiveness and safety of the new drug in multiple double-blind, placebo-controlled studies with approximately 500 individuals with peanut allergies. Based on those studies, the potential side effects of Palforzia include abdominal pain, itching, tingling in the mouth, nausea, vomiting, cough, runny nose, throat irritation, tightness, hives, wheezing, shortness of breath and anaphylaxis.
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