ZORYVE Foam Cleared by FDA for Full-Body Psoriasis

The US Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ ZORYVE® (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis in patients aged 12 and older, according to a press release from the manufacturer.

The approval was based on data from the phase 3 ARRECTOR trial and the phase 2 Trial 204, both of which evaluated the efficacy and safety of ZORYVE foam in 736 patients (both adolescent and adult) with mild to severe plaque psoriasis. Both trials met their primary endpoints, showing improvements in Investigator Global Assessment (IGA) scores for both scalp and body lesions.

“Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging. A safe, effective foam offers a much-needed solution,” said Jennifer Soung, MD, Director of Clinical Research at Southern California Dermatology and trial investigator, in the press release. “ZORYVE foam not only effectively cleared psoriasis plaques on the body and scalp but also provided rapid itch relief.”

The product was safe and associated with low adverse event rates comparable to vehicle. Common side effects included headache, diarrhea, and nasopharyngitis.

Source: Arcutis press release. May 22, 2025.