General Information

Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] is an oral immunotherapy.

Palforzia is specifically indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Palforzia is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older.

Palforzia is supplied as a capsule. Open capsule(s) or sachet and empty the entire dose of Palforzia powder onto a few spoonfuls of refrigerated or room temperature semisolid food (e.g., applesauce, yogurt, pudding). Do not use liquid (e.g., milk, water, juice) to prepare. Mix well. Consume the entire volume of the prepared mixture promptly. Dispose of the opened capsule(s) or sachet. Wash hands immediately after handling Palforzia capsule(s) or sachets. Dispose of all unused Palforzia.

Treatment with Palforzia is administered in 3 sequential phases: Initial Dose Escalation, Up-Dosing, and Maintenance. The dose configurations for each phase of dosing are provided in the Palforzia drug label.

Clinical Trials

FDA Approval

The FDA approval of Palforzia was based on the PALISADE (Peanut ALlergy oral Immunotherapy Study of AR101 for DEsensitization in children and adults) was an international, randomized 3:1, double-blind, placebo-controlled trial of the efficacy and safety of AR101 in a Characterized Oral Desensitization ImmunoTherapy (CODIT) approach in patients with peanut allergy. PALISADE enrolled 554 peanut-allergic patients ages 4–49, all of whom had to experience dose-limiting symptoms at or before the 100-mg dose of peanut protein in an entry double-blind, placebo-controlled food challenge (DBPCFC), which allowed consecutive doses of 1, 3, 10, 30 and 100 mg of peanut protein, given 20 to 30 minutes apart. Patients enrolled in PALISADE underwent a dose escalation period of approximately 22 weeks to reach a maintenance dose of 300 mg per day of AR101 or placebo, then continued with daily maintenance at 300 mg per day of AR101 or placebo for approximately six months. At the end of the maintenance period, patients underwent an exit DBPCFC, which tested consecutive doses of 3, 10, 30, 100, 300, 600 and 1000 mg of peanut protein, given 20 to 30 minutes apart, as tolerated with no or only mild symptoms. The study met the primary efficacy endpoint, as 67.2% of AR101 patients ages 4–17 tolerated at least a 600-mg dose of peanut protein in the exit food challenge, compared to 4.0% of placebo patients. 50.3% of AR101 patients ages 4–17 tolerated a 1000-mg dose of peanut protein in the exit food challenge, compared to 2.4% of placebo patients. Among patients ages 4–17 who completed treatment with AR101, 96.3% tolerated a 300-mg dose of peanut protein in the exit food challenge, 84.5% tolerated a 600-mg dose, and 63.2% tolerated a 1000-mg dose. 79.6% of AR101 patients ages 4–17 completed the trial; of the 20.4% who discontinued treatment, 12.4% withdrew due to treatment-related adverse events.

Side Effects

Adverse effects associated with the use of Palforzia may include, but are not limited to, the following:

abdominal pain

vomiting

nausea

oral pruritus

oral paresthesia

throat irritation

cough

rhinorrhea

sneezing

throat tightness

wheezing

dyspnea

pruritus

urticaria

anaphylactic reaction

ear pruritus

Mechanism of Action

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) is a powder for oral administration. Palforzia is a complex biologic drug used with a structured dosing approach that builds on a century of oral immunotherapy (OIT) research. With OIT, the specific allergenic proteins are ingested initially in very small quantities, followed by incrementally increasing amounts, resulting in the ability to mitigate allergic reactions to the allergen over time. Palforzia is a rigorously developed, pharmaceutical-grade OIT for peanut allergy with a well-defined allergen profile to assure that every dose, whether 0.5 mg (equivalent to 1/600th of a peanut) or 300 mg, has been prepared and analyzed for consistency.