FDA Approves Roflumilast Topical Foam 0.3% for Plaque Psoriasis

Today, the FDA approved roflumilast (Zoryve; Arcutis Biotherapeutics) topical foam 0.3% for the treatment of plaque psoriasis in adults and adolescents 12 years and older.¹

Once-daily roflumilast provides skin clearance, rapid itch relief with no limitation on duration of use. | Image credit: Milan Lipowski - stock.adobe.com

Roflumilast foam is a once-daily steroid-free topical which can be applied to the scalp and body.

“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 statement from Arcutis. “In clinical trials, Zoryve foam not only effectively cleared psoriasis plaques on the body and scalp but also provided rapid itch relief. Zoryve can be safely used for any duration and offers 2 highly convenient formulations, cream or foam, for health care providers to choose from. Zoryve foam allows patients to treat their whole body with one prescription, transforming the treatment landscape for scalp and body psoriasis.”

The approval was supported by positive results from the phase 2 Trial 204 and phase 3 ARRECTOR trials, which evaluated the safety and efficacy of roflumilast foam. The studies enrolled a total of 736 adults and adolescents with mild to severe plaque psoriasis of the scalp and body. In each trial, patients were randomized 2:1 to receive roflumilast foam 0.3% or vehicle foam applied once-daily for 8 weeks.

The ARRECTOR study met its co–primary end points of Scalp-Investigator Global Assessment (S-IGA) Success and Body-Investigator Global Assessment (B-IGA) Success. In total, 66.4% of participants were treated roflumilast foam achieved Scalp-IGA Success at week 8 compared with 27.8% of participants treated with vehicle foam (P < .0001). Additionally, 45.5% of participants achieved BODY-IGA Success at week 8 compared with 20.1% of participants treated with vehicle foam (P < .0001). The researchers defined IGA Success as an IGA score of clear or almost clear plus a 2-point improvement from baseline.

The phase 2 trial also met its primary end point, with 56.7% of participants achieving S-IGA Success at week 8 with roflumilast foam compared with 11.0% of participants treated with matching vehicle foam. Additionally, 39.0% of participants achieved B-IGA Success at week 8 when treated with roflumilast foam compared with 7.4% of participants treated with matching vehicle foam (P < .0001).

Roflumilast also showed clinically meaningful improvement in itch, with 65.3% of individuals achieving significant reduction in itch compared with 30.3% of those treated with vehicle foam at week 8 (P < .0001), as measured by a 4-point or greater change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Moreover, greater improvement in scalp itch was observed in the 24 hours following the first application of roflumilast compared with vehicle foam (P = .0164). This improvement in scalp itch was consistent in the phase 2 trial, with 67.3% of individuals treated with roflumilast achieving SI-NRS Success at Week 8 compared with 20.7% of individuals treated with vehicle foam.

Furthermore, 63.1% of individuals treated with roflumilast foam achieved improvement in body itch, measured by the Worst Itch-Numeric Rating Scale, compared with 30.1% of those treated with vehicle at Week 8 (P < .0001).

Roflumilast was well tolerated, with the most common adverse reactions being headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%) among both trials.

"Living with plaque psoriasis can have a profound impact on people’s emotional well-being, quality of life, and social relationships. This can be even further exacerbated when psoriasis appears on the face, scalp, or thin-skinned areas," Leah Howard, president and CEO, National Psoriasis Foundation, said in the statement. "We are pleased to see new advancements and innovation in treatments for the millions afflicted with this serious skin disease, that can be used long-term and anywhere the disease presents."

Topical roflumilast 0.3% cream has been approved by the FDA to treat plaque psoriasis in patients 12 years and older since 2022, and an oral formulation is also being assessed for moderate to severe psoriasis.

References

1. Arcutis’ Zoryve (roflumilast) topical foam 0.3% approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older. Arcutis Biotherapeutics. News release. May 22, 2025. Accessed May 22, 2025. https://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/

2. Steinzor P. Oral roflumilast shows promise for moderate to severe psoriasis. AJMC^®. February 13, 2025. Accessed May 22, 2025. https://www.ajmc.com/view/oral-roflumilast-shows-promise-for-moderate-to-severe-psoriasis