Officials with the FDA approved roflumilast (Zoryve; Arcutis) foam 0.3% as a once-daily topical treatment for plaque psoriasis in adults and adolescents aged ≥12 years.1
The foam is a next-generation phosphodiesterase-4 inhibitor, offering a nonsteroidal, long-term treatment option for those living with chronic psoriasis.
The approval is supported by positive results from Arcutis’ phase 2 and phase 3 trials in plaque psoriasis. The “A Randomized Trial Employing Topical Roflumilast Foam to Treat Scalp Psoriasis” (ARRECTOR) and the phase 2 (Trial 204) were multicenter, randomized, double-blind, vehicle-controlled studies evaluating the safety and efficacy of Zoryve foam 0.3% in plaque psoriasis. Together the 2 studies enrolled 736 adults and adolescents aged ≥12 years with mild to severe plaque psoriasis of scalp and body. In each trial, subjects were randomly assigned 2:1 to receive the roflumilast foam 0.3% or vehicle foam applied once daily for 8 weeks.
The tested foam provided a clinically meaningful improvement in itch. In ARRECTOR, 65.3% of individuals treated with roflumilast achieved a clinically significant reduction in scalp itch compared with approximately 30.3% of individuals treated with vehicle at week 8 (P<.0001) as measured by a ≥4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Importantly, a greater improvement in scalp itch was observed 24 hours following the first application with Zoryve foam compared with vehicle (as measured by mean SI-NRS change from baseline, relative to vehicle; P=.0164). The improvement in scalp itch was consistent in Trial 204, with a higher percentage of individuals achieving SI-NRS success at week 8 with roflumilast foam compared with vehicle (67.3% vs 20.7%).
In addition, the Zoryve foam also provided improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS), with 63.1% of those treated with foam achieving a ≥4-point reduction in WI-NRS compared with 30.1% of those treated with vehicle at week 8 (P<.0001) in ARRECTOR.
“Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging. A safe, effective foam offers a much-needed solution,” Jennifer Soung, MD, director of clinical research at Southern California Dermatology, and clinical trial investigator, said in a press release about the approval. “In clinical trials, Zoryve foam not only effectively cleared psoriasis plaques on the body and scalp, but also provided rapid itch relief.”
Reference
- Arcutis Biotherapeutics. Arcutis’ Zorvye (roflumilast) topical foam 0.3% approved by U.S. FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older - Arcutis Biotherapeutics. May 22, 2025. Accessed July 8, 2025. www.arcutis.com/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-the-treatment-of-plaque-psoriasis-in-adults-and-adolescents-ages-12-and-older/